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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFLUOROPERM RGP CONTACT LENSES
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namefluoro-siloxane acrylate contact lens
Regulation Number886.5916
ApplicantPARAGON VISION SCIENCES
PMA NumberP870024
Date Received05/20/1987
Decision Date12/31/1987
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 88M-0013
Notice Date 02/22/1988
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 
S020 S022 S023 S024 S025 S026 
S027 S029 S030 S031 S032 S033 
S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 
S046 S047 
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