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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYSKON HYSTEROSCOPY FLUID
Classification Namefluid, hysteroscopy
Generic Namefluid, hysteroscopy
Applicant
COOPERVISION SURGICAL
95 corporate dr.
trumbull, CT 06611
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 - manufacturer/sterilizer/packager/supplier
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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