T34L SYRINGE DRIVER


Device Classification Name

pump, infusion

510(k) Number K080954
Device Name T34L SYRINGE DRIVER
Applicant
CAESAREA MEDICAL ELECTRONICS LTD.
16 shacham street
industrial park
caesarea, 

IL

38900

Applicant Contact eva partas
Correspondent
CAESAREA MEDICAL ELECTRONICS LTD.
16 shacham street
industrial park
caesarea, 

IL

38900

Correspodent Contact eva partas
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MEA  
Date Received 04/03/2008
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No