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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.
 
DeviceMODELS B-13F (P-10) & B-1H (P-11)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP810032
Date Received07/08/1981
Decision Date04/23/1982
Product Code HQL 
Docket Number 82M-0142
Notice Date 05/25/1982
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S003 S004 S005 S006 S007 S008 S010 S011 S012 S013 
S014 S015 S016 S017 S020 S021 S024 S025 S026 S027 S028 S030 
S041 S042 S043 S044 S045 S047 S048 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 
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