Device Classification Name |
system, dialysate delivery, central multiple patient
|
510(k) Number |
K802297 |
Device Name |
PORTADIAL CARRY-ON KIDNEY MACHINE |
Applicant |
ALAN P. KENDAL, PH.D. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ALAN P. KENDAL, PH.D. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/19/1980 |
Decision Date | 05/01/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|