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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHYSKON HYSTEROSCOPY FLUID
Classification Namefluid, hysteroscopy
Generic Namehysteroscopy fluid
ApplicantCOOPERSURGICAL, INC.
PMA NumberN17511
Supplement NumberS013
Date Received01/10/2000
Decision Date02/09/2000
Product Code
LTA
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device.
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