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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHYSKON (32% DEXTRAN 70)
Generic NameFLUID, HYSTEROSCOPY
ApplicantCOOPERVISION SURGICAL
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberN17511
Date Received07/07/1975
Decision Date09/15/1975
Withdrawal Date 04/14/2009
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 
S013 S014 S015 
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