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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS
Classification Namelenses, soft contact, extended wear
Generic Namesoft contact lens
Regulation Number886.5925
ApplicantUNILENS CORP., USA
PMA NumberP890040
Supplement NumberS004
Date Received11/25/1991
Decision Date06/29/1992
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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