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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 K031521
Device Name AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Applicant
CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH,  GA  30097
Applicant Contact STEVEN DOWDLEY
Correspondent
CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH,  GA  30097
Correspondent Contact STEVEN DOWDLEY
Regulation Number886.5928
Classification Product Code
LPN  
Date Received05/15/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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