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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.
 
DevicePAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES
Classification Namelens, contact (orthokeratology)
Generic Namelens, contact (orthokeratology)
Regulation Number886.5916
Applicant
PARAGON VISION SCIENCES
947 east impala ave.
mesa, AZ 85204
PMA NumberP870024
Supplement NumberS044
Date Received08/31/2004
Decision Date09/24/2004
Product Code
MUW[ Registered Establishments with MUW ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of a specific process of manufacture to reduce the hydration time and improve the comfort for the contact lens user.
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