Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K121269 |
Device Name |
TBA |
Applicant |
MIGADA PLANT |
NORTH INDUSTRIAL ZONE |
KIRYAT SHMONA,
IL
10258
|
|
Applicant Contact |
YOSSI SHACHAR |
Correspondent |
MIGADA PLANT |
NORTH INDUSTRIAL ZONE |
KIRYAT SHMONA,
IL
10258
|
|
Correspondent Contact |
YOSSI SHACHAR |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/26/2012 |
Decision Date | 01/22/2013 |
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
|
|
|