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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 NameCIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC
Classification Nameintraocular lens
Generic Namecircular open loop posterior iols & elliptical
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP820072
Date Received09/30/1982
Decision Date07/21/1983
Withdrawal Date 04/06/2009
Product Code
HQL[ Registered Establishments with HQL ]
Notice Date 08/09/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 S004 S005 S006 S007 S008 S010 S011 
S012 S013 S014 S017 S018 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S031 S032 S033 
S034 S035 
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