Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K111016 |
Device Name |
SAFEPORT MANIFOLD (TM) (OR STOPCOCK) |
Applicant |
ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM |
D.N. MEROM HAGALIL,
IL
13860
|
|
Applicant Contact |
NATASHA EVRONYAN |
Correspondent |
ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM |
D.N. MEROM HAGALIL,
IL
13860
|
|
Correspondent Contact |
NATASHA EVRONYAN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/12/2011 |
Decision Date | 06/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|