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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 K042176
Device Name AQUIFY LENS COMFORT DROPS
Applicant
CIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH,  GA  30097
Applicant Contact STEVEN DOWDLEY
Correspondent
CIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH,  GA  30097
Correspondent Contact STEVEN DOWDLEY
Regulation Number886.5928
Classification Product Code
LPN  
Date Received08/11/2004
Decision Date 11/03/2004
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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