Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K140730 |
Device Name |
VIAL2BAG DIRECT CONNECT |
Applicant |
MEDIMOP MEDICAL PROJECTS, LTD. |
17 HATIDHAR ST. |
RA'ANANA,
IL
4366519
|
|
Applicant Contact |
ILANIT GOLDGRABER |
Correspondent |
MEDIMOP MEDICAL PROJECTS, LTD. |
17 HATIDHAR ST. |
RA'ANANA,
IL
4366519
|
|
Correspondent Contact |
ILANIT GOLDGRABER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/24/2014 |
Decision Date | 06/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|