Title 21

SECTION 878.4760

878.4760 Removable skin staple.

§ 878.4760 Removable skin staple.

(a) Identification. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.

(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 65 FR 2318, Jan. 14, 2000]