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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 NamePARAPERM E.W. (PASIFOCON C) RGP GRAY TINT
Classification Namelens, contact (other material) - daily
Generic Nameblue rigid gas permeable contact lens
Regulation Number886.5916
ApplicantPARAGON OPTICAL CO.
PMA NumberP850038
Supplement NumberS018
Date Received02/11/1992
Decision Date06/12/1992
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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