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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 K120769
Device Name MODULTH SLK
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo,  CA  90245
Contact leigh spotten
Regulation Number876.5990
Classification Product Code
LNS  
Date Received03/14/2012
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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