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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 K032030
FOIA Releasable 510(k) K032030
Device Name BLINK CL LUBRICANT EYE DROPS
Applicant
Advanced Medical Optics, Inc.
1700 E. St. Andrew Place
P.O. Box 25162
Santa Ana,  CA  92705 -4933
Applicant Contact PAUL J NOWACKI
Correspondent
Advanced Medical Optics, Inc.
1700 E. St. Andrew Place
P.O. Box 25162
Santa Ana,  CA  92705 -4933
Correspondent Contact PAUL J NOWACKI
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received07/01/2003
Decision Date 09/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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