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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K860065Substantially Equivalent

Slush Pan Cover

O.R. Concepts, Inc., Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860065 is the FDA 510(k) clearance record for SLUSH PAN COVER, cleared for O.R. Concepts, Inc. on . FDA records list 34 510(k) clearances for O.R. Concepts, Inc., from to . As of , FDA records show no recalls naming K860065.

Clearance record

Decision date
Received
(32 days to decision)
Review panel
Unknown
Applicant
O.R. Concepts, Inc. 1328 Shady Springs Ct., Irving TX
Third party review
No