Device Classification Name |
dialyzer, parallel flow
|
510(k) Number |
K801451 |
Device Name |
ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM |
Applicant |
MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/23/1980 |
Decision Date | 09/26/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|