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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 NameFLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS
Classification Namelens, contact (other material) - daily
Generic Namefluoro-siloxane acrylate contact lens
Regulation Number886.5916
ApplicantPARAGON OPTICAL CO.
PMA NumberP870024
Supplement NumberS025
Date Received04/18/1991
Decision Date06/28/1991
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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