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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade Name(MAFILCON) SOFT CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Generic Namehydrophilic contact lens, (mafilcon)
Regulation Number886.5925
ApplicantN&N MENICON, INC.
PMA NumberP800031
Supplement NumberS001
Date Received11/04/1988
Decision Date05/05/1989
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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