SAFEPORT MANIFOLD (TM) (OR STOPCOCK)


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

Correspodent Contact natasha evronyan
Regulation Number 880.5440
Classification Product Code
FPA  
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