21 C.F.R. PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart A--GENERAL PROVISIONS
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Effective dates of requirement for premarket approval.
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--OBSTETRICAL AND GYNECOLOGICAL DIAGNOSTIC DEVICES
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Viscometer for cervical mucus.
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Endometrial suction curette and accessories.
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Uterotubal carbon dioxide insufflator and accessories.
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Amniotic fluid sampler (amniocentesis tray).
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Transabdominal amnioscope (fetoscope) and accessories.
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Culdoscope and accessories.
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Transcervical endoscope (amnioscope) and accessories.
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Hysteroscope and accessories.
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Hysteroscopic insufflator.
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Gynecologic laparoscope and accessories.
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Laparoscopic insufflator.
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Subpart C--OBSTETRICAL AND GYNECOLOGICAL MONITORING DEVICES
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Obstetric-gynecologic ultrasonic imager.
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Fetal electroencephalographic monitor.
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Fetal phonocardiographic monitor and accessories.
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Fetal ultrasonic monitor and accessories.
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Fetal scalp circular (spiral) electrode and applicator.
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Fetal scalp clip electrode and applicator.
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Intrauterine pressure monitor and accessories.
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External uterine contraction monitor and accessories.
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Home uterine activity monitor.
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Perinatal monitoring system and accessories.
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Obstetric ultrasonic transducer and accessories.
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Telethermographic system.
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Liquid crystal thermographic system.
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Breast lesion documentation system.
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Subpart D--OBSTETRICAL AND GYNECOLOGICAL PROSTHETIC DEVICES
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Fallopian tube prosthesis.
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Subpart E--OBSTETRICAL AND GYNECOLOGICAL SURGICAL DEVICES
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Endoscopic electrocautery and accessories.
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Gynecologic electrocautery and accessories.
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Bipolar endoscopic coagulator-cutter and accessories.
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Unipolar endoscopic coagulator-cutter and accessories.
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Expandable cervical dilator.
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Hygroscopic Laminaria cervical dilator.
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Vibratory cervical dilators.
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Obstetric fetal destructive instrument.
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Obstetric-gynecologic general manual instrument.
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Obstetric-gynecologic specialized manual instrument.
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Gynecologic surgical laser.
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Obstetric table and accessories.
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Subpart F--OBSTETRICAL AND GYNECOLOGICAL THERAPEUTIC DEVICES
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Metreurynter-balloon abortion system.
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Obstetric anesthesia set.
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Abdominal decompression chamber.
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Condom with spermicidal lubricant.
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Contraceptive diaphragm and accessories.
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Contraceptive intrauterine device (IUD) and introducer.
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Contraceptive tubal occlusion device (TOD) and introducer.
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Scented or scented deodorized menstrual pad.
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Scented or scented deodorized menstrual tampon.
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Unscented menstrual tampon.
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Therapeutic vaginal douche apparatus.
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Powered vaginal muscle stimulator for therapeutic use.
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Genital vibrator for therapeutic use.
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Clitoral engorgement device.
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Subpart G--ASSISTED REPRODUCTION DEVICES
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Assisted reproduction needles.
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Assisted reproduction catheters.
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Assisted reproduction accessories.
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Assisted reproduction microtools.
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Assisted reproduction micropipette fabrication instruments.
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Assisted reproduction micromanipulators and microinjectors.
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Assisted reproduction labware.
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Assisted reproduction water and water purification systems.
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Reproductive media and supplements.
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Assisted reproductive microscopes and microscope accessories.
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Assisted reproduction laser system.
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