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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 K042562
Device Name LENS PLUS REWETTING DROPS
Applicant
Advanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana,  CA  92705
Applicant Contact PETER XU
Correspondent
Advanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana,  CA  92705
Correspondent Contact PETER XU
Regulation Number886.5928
Classification Product Code
LPN  
Date Received09/21/2004
Decision Date 07/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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