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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameALLERGAN(R) REWETTING DROPS
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALLERGAN OPTICAL
PMA NumberP910075
Supplement NumberS002
Date Received08/02/1993
Decision Date03/23/1995
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
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