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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 K000164
Device Name COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
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 Received01/19/2000
Decision Date 06/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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