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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 NamePOLYMACON CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantO.S.I. CORP.
PMA NumberP780007
Supplement NumberS038
Date Received05/11/1992
Decision Date04/12/1993
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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