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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 K952152
Device Name PROCLEAR DAILY WEAR CONTACT LENS
Applicant
Biocompatibles , Ltd.
Brunel Science Park
Kingston Ln. Uxbridge
Middlesex, England,  GB UB8 3PQ
Applicant Contact Neil McLachlan
Correspondent
Biocompatibles , Ltd.
Brunel Science Park
Kingston Ln. Uxbridge
Middlesex, England,  GB UB8 3PQ
Correspondent Contact Neil McLachlan
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/08/1995
Decision Date 07/27/1995
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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