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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 K030092
Device Name COMPLETE BRAND MULTI-PURPOSE SOLUTION
Applicant
Advanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana,  CA  92705
Applicant Contact PAUL J NOWACKI
Correspondent
Advanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana,  CA  92705
Correspondent Contact PAUL J NOWACKI
Regulation Number886.5928
Classification Product Code
LPN  
Date Received01/10/2003
Decision Date 04/04/2003
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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