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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 NumberS002
Date Received12/14/1998
Decision Date02/26/1999
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 
Approval to change the sterilization site for the disposable ph electrode to lr plast a/s, formervangen 14-16, dk-2600 glostrup, denmark, and to change the method of sterilization to electron beam irradiation.
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