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
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K822713Substantially Equivalent

Derm-a-Tec Skin Barrier Film

Professional Medical Products, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822713 is the FDA 510(k) clearance record for DERM-A-TEC SKIN BARRIER FILM, cleared for Professional Medical Products, Inc. on . FDA records list 9 510(k) clearances for Professional Medical Products, Inc., from to . As of , FDA records show no recalls naming K822713.

Clearance record

Decision date
Received
(91 days to decision)
Review panel
Unknown
Applicant
Professional Medical Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No