Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K874872 |
Device Name |
FRESENIUS HEMOFLOW F3, F4, F5, F7 |
Applicant |
SERATRONICS, INC. |
4090 PIKE LN. |
CONCORD,
CA
94520
|
|
Applicant Contact |
THOMAS E CANE |
Correspondent |
SERATRONICS, INC. |
4090 PIKE LN. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
THOMAS E CANE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 11/27/1987 |
Decision Date | 02/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|