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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 K981168
Device Name COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
Applicant
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE,  CA  92623 -9534
Applicant Contact PAUL J NOWACKI
Correspondent
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE,  CA  92623 -9534
Correspondent Contact PAUL J NOWACKI
Regulation Number886.5928
Classification Product Code
LPN  
Date Received04/01/1998
Decision Date 09/01/1998
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
Recalls CDRH Recalls
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