Device Classification Name |
Apparatus, Hemoperfusion, Sorbent
|
510(k) Number |
K133807 |
Device Name |
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT |
Applicant |
GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY |
SUITE 400 |
LAKEWOOD,
CO
80401
|
|
Applicant Contact |
KAE MILLER |
Correspondent |
GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY |
SUITE 400 |
LAKEWOOD,
CO
80401
|
|
Correspondent Contact |
KAE MILLER |
Regulation Number | 876.5870
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/16/2013 |
Decision Date | 03/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|