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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 NameSK15 AND SK16
Classification Nameintraocular lens
Generic Nameposterior chamber-iol
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP870045
Date Received07/28/1987
Decision Date01/24/1990
Withdrawal Date 04/06/2009
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 90M-0053
Notice Date 02/27/1990
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S003 S004 S005 S006 S007 S008 S009 S010 S011 
S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S031 S032 S033 S034 
S035 S036 S039 S040 
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