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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSTORZ MODULITH (TM) LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
PMA NumberP920051
Date Received11/24/1992
Decision Date02/17/1995
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 95m-0396
Notice Date 12/15/1995
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Storz modulith lithotripter, model sl20 - the device is an extracorporeal shock wave lithotripter.
Supplements: S001 S002 S003 S004 S005 S006 S007 
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