Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K864169 |
Device Name |
FRESENIUS HEMOFLOW F50 & F70 |
Applicant |
SERATRONICS, INC. |
4090 PIKE LN. |
CONCORD,
CA
94520
|
|
Applicant Contact |
SCOTT N WALKER |
Correspondent |
SERATRONICS, INC. |
4090 PIKE LN. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
SCOTT N WALKER |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 10/24/1986 |
Decision Date | 11/06/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|