Device Classification Name |
System, Dialysate Delivery, Sorbent Regenerated
|
510(k) Number |
K801385 |
Device Name |
K1 POTASSIUM ACETATE ADDITIVE |
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 | 06/13/1980 |
Decision Date | 07/21/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|