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. |
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Trade Name | EXCORIM IMMUNOADSORPTION SYSTEM |
Classification Name | columns, immunoadsorption in extracorporeal systems |
Generic Name | columns, immunoadsorption in extracorporeal systems |
Applicant |
FRESENIUS MEDICAL CARE |
95 hayden ave. |
lexington, MA 02420 |
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HDE Number | H970004 |
Supplement Number | S002 |
Date Received | 12/14/1998 |
Decision Date | 02/26/1999 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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