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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 92,60,30(PAFLUFOCON A,B,C )RGP LENSES
Classification Namelens, contact (other material) - daily
Generic Namefluoro-siloxane acrylate contact lens
Regulation Number886.5916
ApplicantPARAGON OPTICAL CO.
PMA NumberP870024
Supplement NumberS041
Date Received05/12/1997
Decision Date08/25/1997
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for viscon contact lens manufacturing ltd. , 10214-112 street, edmonton, alberta, canada t5k1m4, as an alternate manufacturing and distribution site for the device.
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