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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
1400 north goodman street
rochester, NY 14609
PMA NumberP860002
Date Received01/06/1986
Decision Date10/31/1986
Withdrawal Date 11/26/2008
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 86M-0469
Notice Date 12/16/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S005 S006 S009 S010 S012 S013 S014 
S015 S016 S017 S018