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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 |
|
HDE Number | H970004 |
Supplement Number | S003 |
Date Received | 11/21/2001 |
Decision Date | 01/24/2002 |
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 Transfer of the excorim immunoadsorption system production facility from excorim ab, lund sweden to fresenius hemocare, inc. , 6675 185th ave. Ne, redmond, wa 98052. |