STORZ MODULITH LITHOTRIPTER SLX-F2-F180


Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K072788
Device Name STORZ MODULITH LITHOTRIPTER SLX-F2-F180
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Applicant Contact crystal dizol
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Correspodent Contact crystal dizol
Regulation Number 876.5990
Classification Product Code
LNS  
Date Received 10/01/2007
Decision Date 12/26/2007
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