Absorbable hemostatic agent and dressing.

21 C.F.R. § 878.4490
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
(a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.

Starting a business? Corpus forms LLCs in all 50 states and DC.