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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842814
Device Name PERMALID LINER PAK
Applicant
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Correspondent
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Date Received07/18/1984
Decision Date 08/01/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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