Device Classification Name |
System, Peritoneal, Automatic Delivery
|
510(k) Number |
K002892 |
FOIA Releasable 510(k) |
K002892
|
Device Name |
FRSENIUS PD IQCARD CYCLER |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02420 -9192
|
|
Applicant Contact |
ARTHUR EILINSFEILD |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02420 -9192
|
|
Correspondent Contact |
ARTHUR EILINSFEILD |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 09/15/2000 |
Decision Date | 04/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|