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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.
 
DeviceCUSTOMEYES(TM) 45L&55L (BUFILCON A)
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
CIBA VISION CORPORATION
11460 johns creek parkway
duluth, GA 30097
PMA NumberP850057
Supplement NumberS001
Date Received07/28/1986
Decision Date05/08/1987
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 87M-0191
Notice Date 06/29/1987
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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