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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K812481Substantially Equivalent

Backrest

Maddak, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812481 is the FDA 510(k) clearance record for BACKREST, cleared for Maddak, Inc. on . FDA records list 51 510(k) clearances for Maddak, Inc., from to . As of , FDA records show no recalls naming K812481.

Clearance record

Decision date
Received
(14 days to decision)
Review panel
Unknown
Applicant
Maddak, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No