2001 CFR Title 21, Volume 8

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
	878.1	Scope.
	878.3	Effective dates of requirement for premarket approval.
	878.9	Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
	878.1800	Speculum and accessories.
	878.3250	External facial fracture fixation appliance.
	878.3300	Surgical mesh.
	878.3500	Polytetrafluoroethylene with carbon fibers composite implant material.
	878.3530	Silicone inflatable breast prosthesis.
	878.3540	Silicone gel-filled breast prosthesis.
	878.3550	Chin prosthesis.
	878.3590	Ear prosthesis.
	878.3610	Esophageal prosthesis.
	878.3680	Nose prosthesis.
	878.3720	Tracheal prosthesis.
	878.3750	External prosthesis adhesive.
	878.3800	External aesthetic restoration prosthesis.
	878.3900	Inflatable extremity splint.
	878.3910	Noninflatable extremity splint.
	878.3925	Plastic surgery kit and accessories.
	878.4014	Nonresorbable gauze/sponge for external use.
	878.4018	Hydrophilic wound dressing.
	878.4020	Occlusive wound dressing.
	878.4022	Hydrogel wound dressing and burn dressing.
	878.4040	Surgical apparel.
	878.4100	Organ bag.
	878.4160	Surgical camera and accessories.
	878.4200	Introduction/drainage catheter and accessories.
	878.4300	Implantable clip.
	878.4320	Removable skin clip.
	878.4350	Cryosurgical unit and accessories.
	878.4370	Surgical drape and drape accessories.
	878.4380	Drape adhesive.
	878.4400	Electrosurgical cutting and coagulation device and accessories.
	878.4440	Eye pad.
	878.4450	Nonabsorbable gauze for internal use.
	878.4460	Surgeon's glove.
	878.4470	Surgeon's gloving cream.
	878.4480	Absorbable powder for lubricating a surgeon's glove.
	878.4490	Absorbable hemostatic agent and dressing.
	878.4493	Absorbable poly(glycolide/l-lactide) surgical suture.
	878.4495	Stainless steel suture.
	878.4520	Polytetrafluoroethylene injectable.
	878.4580	Surgical lamp.
	878.4630	Ultraviolet lamp for dermatologic disorders.
	878.4635	Ultraviolet lamp for tanning.
	878.4660	Skin marker.
	878.4680	Nonpowered, single patient, portable suction apparatus.
	878.4700	Surgical microscope and accessories.
	878.4730	Surgical skin degreaser or adhesive tape solvent.
	878.4750	Implantable staple.
	878.4760	Removable skin staple.
	878.4780	Powered suction pump.
	878.4800	Manual surgical instrument for general use.
	878.4810	Laser surgical instrument for use in general and plastic surgery and in dermatology.
	878.4820	Surgical instrument motors and accessories/attachments.
	878.4830	Absorbable surgical gut suture.
	878.4930	Suture retention device.
	878.4950	Manual operating table and accessories and manual operating chair and accessories.
	878.4960	Operating tables and accessories and operating chairs and accessories.
	878.5000	Nonabsorbable poly(ethylene terephthalate) surgical suture.
	878.5010	Nonabsorbable polypropylene surgical suture.
	878.5020	Nonabsorbable polyamide surgical suture.
	878.5030	Natural nonabsorbable silk surgical suture.
	878.5035	Nonabsorbable expanded polytetrafluoroethylene surgical suture.
	878.5040	Suction lipoplasty system.
	878.5070	Air-handling apparatus for a surgical operating room.
	878.5350	Needle-type epilator.
	878.5360	Tweezer-type epilator.
	878.5650	Topical oxygen chamber for extremities.
	878.5900	Nonpneumatic tourniquet.
	878.5910	Pneumatic tourniquet.