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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameEXCORIM IMMUNOADSORPTION SYSTEM
Classification Namecolumns, immunoadsorption in extracorporeal systems
Generic Namecolumns, immunoadsorption in extracorporeal systems
Applicant
Fresenius Medical Care
95 hayden ave.
lexington, MA 02420
HDE NumberH970004
Supplement NumberS001
Date Received11/17/1998
Decision Date12/17/1999
Product Code
LQQ[ Registered Establishments with LQQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Change in the ethylene oxide sterilization site for the medical lines.
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