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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 NameFLUOROCON TM-60
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namefluorocon 60
Regulation Number886.5916
ApplicantCIBA VISION CORPORATION
PMA NumberP890020
Date Received03/20/1989
Decision Date06/23/1989
Withdrawal Date 04/24/2013
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 89M-0313
Notice Date 08/24/1989
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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