21 C.F.R. § 878.4490

Current through October 31, 2024
Section 878.4490 - Absorbable hemostatic agent and dressing
(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 .

21 C.F.R. §878.4490