Device Classification Name |
Container, I.V.
|
510(k) Number |
K001461 |
Device Name |
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET |
Applicant |
BIOMETRIX LTD. |
4 KIRYAT MADA |
P.O. BOX 45057 |
JERUSALEM,
IL
91450
|
|
Applicant Contact |
MIRIAM ABUTBUL |
Correspondent |
BIOMETRIX LTD. |
4 KIRYAT MADA |
P.O. BOX 45057 |
JERUSALEM,
IL
91450
|
|
Correspondent Contact |
MIRIAM ABUTBUL |
Regulation Number | 880.5025
|
Classification Product Code |
|
Date Received | 05/10/2000 |
Decision Date | 09/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|