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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 K003031
Device Name LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
Applicant
Alpha Vista, Inc.
42 Digital Dr., Suite 12
Novata,  CA  94949
Applicant Contact HELMUT WEBER
Correspondent
Alpha Vista, Inc.
42 Digital Dr., Suite 12
Novata,  CA  94949
Correspondent Contact HELMUT WEBER
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received09/28/2000
Decision Date 01/05/2001
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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