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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 K091339
Device Name BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
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  
Subsequent Product Code
MVN  
Date Received05/06/2009
Decision Date 01/05/2010
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
Recalls CDRH Recalls
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