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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853631
Device Name POLY-SLEEVE
Applicant
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Applicant Contact DAVID W KRAPF
Correspondent
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Correspondent Contact DAVID W KRAPF
Date Received08/30/1985
Decision Date 11/01/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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