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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameUNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL.
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALLERGAN, INC.
PMA NumberP840066
Supplement NumberS029
Date Received10/03/1991
Decision Date02/29/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the unpreserved formulation of consept-2 neutralizing and rinsing solution to be packaged in a non-aerosol multi-dose 8 and 12 fluid pz containers with a filter/valve closure system labeled with a discard date of 60 days.
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