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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCUSTOMFLEX (DELTAFILCON A) HYDROPHILIC CONTACT LEN
Classification Namelenses, soft contact, daily wear
Generic Namesoft contact lens
Regulation Number886.5925
ApplicantFRIGITRONICS OF CONNECTICUT, INC.
PMA NumberN18180
Supplement NumberS003
Date Received01/19/1981
Decision Date05/11/1981
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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