Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K913526 |
Device Name |
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS |
Applicant |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014 -9308
|
|
Applicant Contact |
MARIAN D HARDING |
Correspondent |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014 -9308
|
|
Correspondent Contact |
MARIAN D HARDING |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/08/1991 |
Decision Date | 11/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|