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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSOFT MATE COMFORT DROPS
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALLERGAN, INC.
PMA NumberP800018
Supplement NumberS020
Date Received01/27/1995
Decision Date10/31/1995
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate sterilization facility located at sterigenics (formerly radiation sterilization, inc. ), 344 bonnie circle, corona, ca, for the gamma irradiation of the container/closure components for the above-referenced devices.
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