21 C.F.R. § 878.4493 Absorbable poly(glycolide/l -lactide) surgical suture.
Title 21 - Food and Drugs
(a) Identification. An absorbable poly(glycolide/ (b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See §878.1(e) for the availability of this guidance document. [56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4493 Absorbable poly(glycolide/