Device Classification Name |
stopcock, i.v. set
|
510(k) Number |
K141254 |
Device Name |
ELCAM STOPCOCKS AND MANIFOLDS |
Applicant |
ELCAM MEDICAL ACAL |
KIBBUTZ BARAM |
MP MEROM HAGALIL,
IL
1386000
|
|
Applicant Contact |
NATASHA BRANZBURG |
Correspondent |
ELCAM MEDICAL ACAL |
KIBBUTZ BARAM |
MP MEROM HAGALIL,
IL
1386000
|
|
Correspondent Contact |
NATASHA BRANZBURG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/14/2014 |
Decision Date | 07/30/2014 |
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
|
Recalls |
CDRH Recalls
|
|
|