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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 NameND:YAG POSTERIOR CAPSULOTOMY MODEL 100
Classification Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Generic Namend:yag laser
ApplicantNIDEK, INC.
PMA NumberP830062
Date Received01/25/1983
Decision Date09/27/1984
Withdrawal Date 11/27/2013
Product Code
LOI
Docket Number 84M-0353
Notice Date 11/26/1984
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S006 S007 S009 S010 S011 S012 S014 
S015 S016 
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