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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 K072788
Device Name STORZ MODULITH LITHOTRIPTER SLX-F2-F180
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact CRYSTAL DIZOL
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact CRYSTAL DIZOL
Regulation Number876.5990
Classification Product Code
LNS  
Date Received10/01/2007
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
Predetermined Change
Control Plan Authorized		 No
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