Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K854271 |
Device Name |
ASA BLOOD TUBING LINES |
Applicant |
ORGANON TEKNIKA CORP. |
5300 SOUTH PORTLAND AVE. |
OKLAHOMA CITY,
OK
73119
|
|
Applicant Contact |
MARING ROBERTS |
Correspondent |
ORGANON TEKNIKA CORP. |
5300 SOUTH PORTLAND AVE. |
OKLAHOMA CITY,
OK
73119
|
|
Correspondent Contact |
MARING ROBERTS |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 10/23/1985 |
Decision Date | 11/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|