510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K853631Substantially Equivalent

Poly-Sleeve

CooperVision, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853631 is the FDA 510(k) clearance record for POLY-SLEEVE, cleared for CooperVision, Inc. on . FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K853631.

Clearance record

Decision date
Received
(63 days to decision)
Review panel
Unknown
Applicant
CooperVision, Inc. 17701 Cowan Ave.P. O. Box, Irvine CA
Third party review
No