510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850881Substantially Equivalent

Alba Dry Burn Pad

Alba Health Care, Valdese NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850881 is the FDA 510(k) clearance record for ALBA DRY BURN PAD, cleared for Alba Health Care on . FDA records list 8 510(k) clearances for Alba Health Care, from to . As of , FDA records show no recalls naming K850881.

Clearance record

Decision date
Received
(44 days to decision)
Review panel
Unknown
Applicant
Alba Health Care Post Office Box 100, Valdese NC
Third party review
No