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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 K984383
Device Name ULTRACARE NEUTRALIZING TABLETS
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 Received12/08/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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