Device Classification Name |
arterial blood sampling kit
|
510(k) Number |
K902881 |
Device Name |
LAB-SITE SAFETY NEEDLE |
Applicant |
MIGADA, LTD. |
P.O. BOX 2 |
ASHDOD 77100 |
ISRAEL,
IL
|
|
Applicant Contact |
SHMUEL FREEMAN |
Correspondent |
MIGADA, LTD. |
P.O. BOX 2 |
ASHDOD 77100 |
ISRAEL,
IL
|
|
Correspondent Contact |
SHMUEL FREEMAN |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 07/02/1990 |
Decision Date | 09/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|