21 C.F.R. § 878.3925 Plastic surgery kit and accessories.
Title 21 - Food and Drugs
(a) Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §878.9. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart D—Prosthetic Devices
§ 878.3925 Plastic surgery kit and accessories.
