21 C.F.R. PART 878--GENERAL AND PLASTIC SURGERY DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 878--GENERAL AND PLASTIC SURGERY 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--DIAGNOSTIC DEVICES
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| Speculum and accessories.
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Subpart C--[RESERVED]
Subpart D--PROSTHETIC DEVICES
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| External facial fracture fixation appliance.
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| Polytetrafluoroethylene with carbon fibers composite implant material.
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| Silicone inflatable breast prosthesis.
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| Silicone gel-filled breast prosthesis.
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| External prosthesis adhesive.
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| External aesthetic restoration prosthesis.
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| Inflatable extremity splint.
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| Noninflatable extremity splint.
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| Plastic surgery kit and accessories.
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Subpart E--SURGICAL DEVICES
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| Nonresorbable gauze/sponge for external use.
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| Hydrophilic wound dressing.
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| Occlusive wound dressing.
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| Hydrogel wound dressing and burn dressing.
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| Surgical camera and accessories.
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| Introduction/drainage catheter and accessories.
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| Cryosurgical unit and accessories.
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| Surgical drape and drape accessories.
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| Electrosurgical cutting and coagulation device and accessories.
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| Low energy ultrasound wound cleaner.
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| Nonabsorbable gauze for internal use.
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| Absorbable powder for lubricating a surgeon's glove.
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| Absorbable hemostatic agent and dressing.
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| Absorbable poly(glycolide/-lactide) surgical suture.
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| Polytetrafluoroethylene injectable.
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| Ultraviolet lamp for dermatologic disorders.
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| Ultraviolet lamp for tanning.
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| Nonpowered, single patient, portable suction apparatus.
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| Surgical microscope and accessories.
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| Surgical skin degreaser or adhesive tape solvent.
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| Manual surgical instrument for general use.
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| Laser surgical instrument for use in general and plastic surgery and in dermatology.
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| Surgical instrument motors and accessories/attachments.
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| Absorbable surgical gut suture.
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| Absorbable polydioxanone surgical suture.
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| Manual operating table and accessories and manual operating chair and accessories.
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| Operating tables and accessories and operating chairs and accessories.
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| Nonabsorbable poly(ethylene terephthalate) surgical suture.
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| Nonabsorbable polypropylene surgical suture.
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| Nonabsorbable polyamide surgical suture.
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| Natural nonabsorbable silk surgical suture.
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| Nonabsorbable expanded polytetrafluoroethylene surgical suture.
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| Suction lipoplasty system.
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Subpart F--THERAPEUTIC DEVICES
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| Air-handling apparatus for a surgical operating room.
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| Topical oxygen chamber for extremities.
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