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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePREFLEX AND FLEXCARE SOL.
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberN18143
Date Received01/24/1979
Decision Date04/26/1982
Withdrawal Date 12/21/2000
Product Code LPN 
Notice Date 06/15/1979
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 
S025 S027 S028 S029 S031 S032 S033 
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