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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 (32% DEXTRAN 70)
Classification Namefluid, hysteroscopy
Generic Namehysteroscopy fluid
ApplicantMEDISAN PHARMACEUTICALS, INC.
PMA NumberN17511
Supplement NumberS011
Date Received11/10/1994
Decision Date07/18/1995
Product Code
LTA
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a lagarde sterilizer, 551015, in your clayton, n. C. Facility to terminally sterilize hyskon hysteroscopy fluid, 32% (dextran 70) in 100 ml to 250 ml glass bottle:transfer of ownership to madisan pharmaceuticals, inc.
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