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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name products, contact lens care, rigid gas permeable
510(k) Number K013204
Device Name AQUIFY LENS COMFORT DROPS
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 Number886.5918
Classification Product Code
MRC  
Date Received09/25/2001
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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