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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.
 
DeviceFLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES
Classification Namelens, contact (other material) - daily
Generic Namelens, contact (other material) - daily
Regulation Number886.5916
Applicant
PARAGON VISION SCIENCES
947 east impala ave.
mesa, AZ 85204
PMA NumberP870024
Supplement NumberS038
Date Received03/24/1993
Decision Date04/14/1993
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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