Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K001107 |
Device Name |
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02173
|
|
Applicant Contact |
ARTHUR EILINSFELD |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02173
|
|
Correspondent Contact |
ARTHUR EILINSFELD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/05/2000 |
Decision Date | 06/23/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|