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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameTHE BOSTON TM CLEANER II
Classification Nameaccessories, soft lens products
Generic Namecleaning solution for rgp contact lenses
Regulation Number886.5928
ApplicantBAUSCH AND LOMB INTERNATIONAL HOLDINGS CORP.
PMA NumberP890054
Supplement NumberS001
Date Received07/22/1994
Decision Date08/15/1994
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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