Device Classification Name |
accessories, blood circuit, hemodialysis
|
510(k) Number |
K022536 |
Device Name |
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR |
Applicant |
FRESENIUS MEDICAL CARE |
95 HAYDEN AVE. |
LEXINGTON,
MA
02420
|
|
Applicant Contact |
ART EILINSFELD |
Correspondent |
FRESENIUS MEDICAL CARE |
95 HAYDEN AVE. |
LEXINGTON,
MA
02420
|
|
Correspondent Contact |
ART EILINSFELD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/01/2002 |
Decision Date | 10/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|