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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 NameMENICON SF-P RGP (MELAFOCON A) CONTACT LENS
Classification Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantMENICON CO. LTD.
PMA NumberP880098
Supplement NumberS001
Date Received07/24/1989
Decision Date02/08/1990
Product Code
LPL[ Registered Establishments with LPL ]
Docket Number 90M-0068
Notice Date 03/08/1990
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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