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SGVClass III

Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

21 CFR 878.4490 / General, Plastic Surgery

SGV is the FDA product code for Agent, Absorbable Hemostatic, Collagen With Polymeric Additives, a class III device type, regulated under 21 CFR 878.4490. FDA's definition for this code reads: "An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SGV
Device name
Agent, Absorbable Hemostatic, Collagen With Polymeric Additives
FDA definition
An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood.
Regulation
21 CFR 878.4490
Device class
Class III
Review panel
General, Plastic Surgery
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code