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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 NameMENICON SF-P RGP (MELAFOCON A) CONTACT LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
ApplicantMENICON CO. LTD.
PMA NumberP880098
Date Received12/16/1988
Decision Date09/01/1989
Withdrawal Date 05/05/2008
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 89M-0388
Notice Date 10/19/1989
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 
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