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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K822541Substantially Equivalent

Visiopal 75

Polycore Optical Pte, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822541 is the FDA 510(k) clearance record for VISIOPAL 75, cleared for Polycore Optical Pte , Ltd. on . FDA records list 7 510(k) clearances for Polycore Optical Pte , Ltd., from to . As of , FDA records show no recalls naming K822541.

Clearance record

Decision date
Received
(126 days to decision)
Review panel
Unknown
Applicant
Polycore Optical Pte , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No