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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K852386
Device Name SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT
Applicant
Barnes-Hind, Inc.
895 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact LARRY K TAMURA
Correspondent
Barnes-Hind, Inc.
895 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact LARRY K TAMURA
Regulation Number886.5928
Classification Product Code
LPN  
Date Received06/05/1985
Decision Date 09/04/1985
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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