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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.
 
DeviceIOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP870013
Date Received03/09/1987
Decision Date03/31/1988
Withdrawal Date 04/06/2009
Product Code HQL 
Docket Number 88M-0159
Notice Date 07/20/1988
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S003 S004 S005 S006 S008 S014 S015 S009 S016 S010 
S011 S012 S013 
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