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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 NameMODELS B-13F (P-10) & B-1H (P-11)
Classification Nameintraocular lens
Generic Nameintraocular lens, posterior chamber
Regulation Number886.3600
PMA NumberP810032
Date Received07/08/1981
Decision Date04/23/1982
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 82M-0142
Notice Date 05/25/1982
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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