Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K063290 |
Device Name |
GAMBRO QUICKSET BLOODLINES |
Applicant |
GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
THOMAS B DOWELL |
Correspondent |
GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
THOMAS B DOWELL |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 11/01/2006 |
Decision Date | 01/30/2007 |
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
|
|
|