Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

TEXT PDF878.1 Scope.
TEXT PDF878.3 Effective dates of requirement for premarket approval.
TEXT PDF878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
TEXT PDF878.1800 Speculum and accessories.
TEXT PDF878.3250 External facial fracture fixation appliance.
TEXT PDF878.3300 Surgical mesh.
TEXT PDF878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
TEXT PDF878.3530 Silicone inflatable breast prosthesis.
TEXT PDF878.3540 Silicone gel-filled breast prosthesis.
TEXT PDF878.3550 Chin prosthesis.
TEXT PDF878.3590 Ear prosthesis.
TEXT PDF878.3610 Esophageal prosthesis.
TEXT PDF878.3680 Nose prosthesis.
TEXT PDF878.3720 Tracheal prosthesis.
TEXT PDF878.3750 External prosthesis adhesive.
TEXT PDF878.3800 External aesthetic restoration prosthesis.
TEXT PDF878.3900 Inflatable extremity splint.
TEXT PDF878.3910 Noninflatable extremity splint.
TEXT PDF878.3925 Plastic surgery kit and accessories.
TEXT PDF878.4014 Nonresorbable gauze/sponge for external use.
TEXT PDF878.4018 Hydrophilic wound dressing.
TEXT PDF878.4020 Occlusive wound dressing.
TEXT PDF878.4022 Hydrogel wound dressing and burn dressing.
TEXT PDF878.4040 Surgical apparel.
TEXT PDF878.4100 Organ bag.
TEXT PDF878.4160 Surgical camera and accessories.
TEXT PDF878.4200 Introduction/drainage catheter and accessories.
TEXT PDF878.4300 Implantable clip.
TEXT PDF878.4320 Removable skin clip.
TEXT PDF878.4350 Cryosurgical unit and accessories.
TEXT PDF878.4370 Surgical drape and drape accessories.
TEXT PDF878.4380 Drape adhesive.
TEXT PDF878.4400 Electrosurgical cutting and coagulation device and accessories.
TEXT PDF878.4440 Eye pad.
TEXT PDF878.4450 Nonabsorbable gauze for internal use.
TEXT PDF878.4460 Surgeon's glove.
TEXT PDF878.4470 Surgeon's gloving cream.
TEXT PDF878.4480 Absorbable powder for lubricating a surgeon's glove.
TEXT PDF878.4490 Absorbable hemostatic agent and dressing.
TEXT PDF878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
TEXT PDF878.4495 Stainless steel suture.
TEXT PDF878.4520 Polytetrafluoroethylene injectable.
TEXT PDF878.4580 Surgical lamp.
TEXT PDF878.4630 Ultraviolet lamp for dermatologic disorders.
TEXT PDF878.4635 Ultraviolet lamp for tanning.
TEXT PDF878.4660 Skin marker.
TEXT PDF878.4680 Nonpowered, single patient, portable suction apparatus.
TEXT PDF878.4700 Surgical microscope and accessories.
TEXT PDF878.4730 Surgical skin degreaser or adhesive tape solvent.
TEXT PDF878.4750 Implantable staple.
TEXT PDF878.4760 Removable skin staple.
TEXT PDF878.4780 Powered suction pump.
TEXT PDF878.4800 Manual surgical instrument for general use.
TEXT PDF878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
TEXT PDF878.4820 Surgical instrument motors and accessories/attachments.
TEXT PDF878.4830 Absorbable surgical gut suture.
TEXT PDF878.4930 Suture retention device.
TEXT PDF878.4950 Manual operating table and accessories and manual operating chair and accessories.
TEXT PDF878.4960 Operating tables and accessories and operating chairs and accessories.
TEXT PDF878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
TEXT PDF878.5010 Nonabsorbable polypropylene surgical suture.
TEXT PDF878.5020 Nonabsorbable polyamide surgical suture.
TEXT PDF878.5030 Natural nonabsorbable silk surgical suture.
TEXT PDF878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
TEXT PDF878.5040 Suction lipoplasty system.
TEXT PDF878.5070 Air-handling apparatus for a surgical operating room.
TEXT PDF878.5350 Needle-type epilator.
TEXT PDF878.5360 Tweezer-type epilator.
TEXT PDF878.5650 Topical oxygen chamber for extremities.
TEXT PDF878.5900 Nonpneumatic tourniquet.
TEXT PDF878.5910 Pneumatic tourniquet.

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