510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842814Substantially Equivalent for Some Indications

Permalid Liner Pak

CooperVision, Inc., Southampton, GB / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K842814 is the FDA 510(k) clearance record for PERMALID LINER PAK, 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 K842814.

Clearance record

Decision date
Received
(379 days to decision)
Review panel
Unknown
Applicant
CooperVision, Inc. Permalens House, Southampton, GB
Third party review
No