AVIAFIT


Device Classification Name

sleeve, limb, compressible

510(k) Number K111720
Device Name AVIAFIT
Applicant
FLOWMEDIC LTD.
20 hataas str.
suite 102
kfar saba, 

IL

44425

Applicant Contact ahava stein
Correspondent
FLOWMEDIC LTD.
20 hataas str.
suite 102
kfar saba, 

IL

44425

Correspodent Contact ahava stein
Regulation Number 870.5800
Classification Product Code
JOW  
Date Received 06/20/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No