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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K012482
Device Name STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact JENNIFER PORTUGAL
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact JENNIFER PORTUGAL
Regulation Number876.5990
Classification Product Code
LNS  
Date Received08/02/2001
Decision Date 10/16/2001
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
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