Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K921597 |
Device Name |
CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 |
Applicant |
HAEMOTRONIC, INC. |
45 KULICK RD. |
FAIRFIELD,
NJ
07004
|
|
Applicant Contact |
WILLER GHELFI |
Correspondent |
HAEMOTRONIC, INC. |
45 KULICK RD. |
FAIRFIELD,
NJ
07004
|
|
Correspondent Contact |
WILLER GHELFI |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/03/1992 |
Decision Date | 02/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|