Device Classification Name |
system, dialysate delivery, sorbent regenerated
|
510(k) Number |
K813574 |
Device Name |
SORB II |
Applicant |
ORGANON TEKNIKA CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ORGANON TEKNIKA CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5600
|
Classification Product Code |
|
Date Received | 12/23/1981 |
Decision Date | 03/23/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|