M/29TM – PRESSURE INJECTABLE


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K111939
Device Name M/29TM – PRESSURE INJECTABLE
Applicant
FLEXICATH LTD.
120 yigal alon st.
california bldg, suite 107
tel aviv, 

IL

67443

Applicant Contact tali hazan
Correspondent
FLEXICATH LTD.
120 yigal alon st.
california bldg, suite 107
tel aviv, 

IL

67443

Correspodent Contact tali hazan
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 07/08/2011
Decision Date 07/11/2012
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