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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, (Disposable)
510(k) Number K061948
Device Name PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT 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
MVN  
Subsequent Product Code
LPL  
Date Received07/10/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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