H-FLOW VALVE

Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K034043
Device Name H-FLOW VALVE
Applicant
ELCAM MEDICAL A.C.A.L.
kibbutz bar-am
d.n. merom hagalil, 

IL

13860

Applicant Contact tali hazan
Correspondent
ELCAM MEDICAL A.C.A.L.
kibbutz bar-am
d.n. merom hagalil, 

IL

13860

Correspodent Contact tali hazan
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 12/29/2003
Decision Date 06/30/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No