[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4490]

[Page 384]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 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 Sec. 878.3.