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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K032873
Device Name PROCLEAR COMPATIBLES MULTIFOCAL
Applicant
CooperVision, Inc.
1215 Boissevain Ave.
Norfolk,  VA  23507
Applicant Contact LISA HAHN
Correspondent
CooperVision, Inc.
1215 Boissevain Ave.
Norfolk,  VA  23507
Correspondent Contact LISA HAHN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/15/2003
Decision Date 11/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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