Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K781142 |
Device Name |
DISSCAP |
Applicant |
|
Correspondent |
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/10/1978 |
Decision Date | 09/14/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|