Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K832547 |
Device Name |
ULTRAFILTRATION CONTROLLER |
Applicant |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/01/1983 |
Decision Date | 01/03/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|