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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 NameKELMAN(TM) OMNIFIT II MODEL 2100
Classification Nameintraocular lens
Generic Nameanterior chamber iols
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP850059
Date Received08/15/1985
Decision Date07/31/1986
Withdrawal Date 11/26/2008
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 87M-0008
Notice Date 02/18/1987
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S016 S017 S018 S019 S020 S021 S022 
S023 S024 
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