Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K100364 |
Device Name |
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 |
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 | 876.5820
|
Classification Product Code |
|
Date Received | 02/12/2010 |
Decision Date | 11/03/2010 |
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
|
|
|