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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
Original Applicant
ALLERGAN, INC.
2525 dupont dr.
p.o. box 19534
irvine,  CA  92623 -9534
Original 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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