SONOLITH I-MOVE


Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K111808
Device Name SONOLITH I-MOVE
Applicant
EDAP TMS FRANCE
columbia square 555
thirteenth street, nw
washington, 
DC 
20004

Applicant Contact holstein howard
Correspondent
EDAP TMS FRANCE
columbia square 555
thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact holstein howard
Regulation Number 876.5990
Classification Product Code
LNS  
Subsequent Product Code
MMZ  
Date Received 06/27/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No