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Electronic Code of Federal Regulations

e-CFR data is current as of February 18, 2020

Title 21Chapter ISubchapter HPart 878Subpart E → §878.4490


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices


§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.

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