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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 K952261
Device Name HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%
Applicant
Pilkington Barnes-Hind, Ltd.
Units 8,9,& 10 Solent Ind Est
Shamblehurst Ln.,Hedge End
Hedge End, Southampton,  GB S03 2FY
Applicant Contact DEBORA D HINMAN
Correspondent
Pilkington Barnes-Hind, Ltd.
Units 8,9,& 10 Solent Ind Est
Shamblehurst Ln.,Hedge End
Hedge End, Southampton,  GB S03 2FY
Correspondent Contact DEBORA D HINMAN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/15/1995
Decision Date 07/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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