510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PFCClass III

Cultured Human Cell Skin Dressing

Unknown
FDA source (opens on fda.gov)

PFC is the FDA product code for Cultured Human Cell Skin Dressing, a class III device type. FDA's definition for this code reads: "Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PFC
Device name
Cultured Human Cell Skin Dressing
FDA definition
Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
Device class
Class III
Review panel
Unknown
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