FLEXI-Q DV AND DVR AUTO-INJECTORS


Device Classification Name

introducer, syringe needle

510(k) Number K111467
Device Name FLEXI-Q DV AND DVR AUTO-INJECTORS
Applicant
ELCAM MEDICAL A.C.A.L.
kibbutz bar-am
d.n. merom hagalil, 

IL

13860

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

IL

13860

Correspodent Contact shay shaham
Regulation Number 880.6920
Classification Product Code
KZH  
Date Received 05/26/2011
Decision Date 02/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No