Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K950247 |
Device Name |
TS 564/PF |
Applicant |
BRESSLER, AMERY & ROSS |
P.O. BOX 1980 |
MORRISTOWN,
NJ
07962
|
|
Applicant Contact |
ERIC J NEMETH |
Correspondent |
BRESSLER, AMERY & ROSS |
P.O. BOX 1980 |
MORRISTOWN,
NJ
07962
|
|
Correspondent Contact |
ERIC J NEMETH |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/20/1995 |
Decision Date | 11/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|