Device Classification Name |
System, Dialysate Delivery, Sorbent Regenerated
|
510(k) Number |
K851188 |
Device Name |
PACKETS FOR PREP. OF DIALYSATES & INFUSATES - |
Applicant |
ORGANON TEKNIKA CORP. |
5300 SOUTH PORTLAND AVE. |
OKLAHOMA CITY,
OK
73119
|
|
Applicant Contact |
MARTIN ROBERTS |
Correspondent |
ORGANON TEKNIKA CORP. |
5300 SOUTH PORTLAND AVE. |
OKLAHOMA CITY,
OK
73119
|
|
Correspondent Contact |
MARTIN ROBERTS |
Regulation Number | 876.5600
|
Classification Product Code |
|
Date Received | 02/28/1985 |
Decision Date | 04/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|