Device Classification Name |
System, Peritoneal, Automatic Delivery
|
510(k) Number |
K844630 |
Device Name |
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM |
Applicant |
ORGANON TEKNIKA CORP. |
5300 SOUTH PORTLAND AVE. |
OKLAHOMA CITY,
OK
73119
|
|
Applicant Contact |
VAN ANTWERPEN |
Correspondent |
ORGANON TEKNIKA CORP. |
5300 SOUTH PORTLAND AVE. |
OKLAHOMA CITY,
OK
73119
|
|
Correspondent Contact |
VAN ANTWERPEN |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 11/27/1984 |
Decision Date | 03/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|