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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 K961299
Device Name PRECISION UV (VASURFILCON A)
Applicant
Pilkington Barnes-Hind, Ltd.
810 Kifer Rd.
Sunnyvale,  CA  94086 -5200
Applicant Contact DEBORA D HINMAN
Correspondent
Pilkington Barnes-Hind, Ltd.
810 Kifer Rd.
Sunnyvale,  CA  94086 -5200
Correspondent Contact DEBORA D HINMAN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/04/1996
Decision Date 10/01/1996
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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