PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER


Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K072538
Device Name PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
Applicant
UNITED MEDICAL SYSTEMS, INC.
700 thirteenth street nw
washington, 
DC 
20005

Applicant Contact jeffrey k shapiro
Correspondent
UNITED MEDICAL SYSTEMS, INC.
700 thirteenth street nw
washington, 
DC 
20005

Correspodent Contact jeffrey k shapiro
Regulation Number 876.5990
Classification Product Code
LNS  
Date Received 09/07/2007
Decision Date 01/30/2008
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