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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantEpcon Laboratories
5927 Cromo
El Paso, TX 79912
PMA NumberP880049
Supplement NumberS001
Date Received01/30/1991
Decision Date07/19/1991
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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