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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 K032958
Device Name PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
Applicant
United Medical Systems, Inc.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JEFFREY K SHAPIRO
Correspondent
United Medical Systems, Inc.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JEFFREY K SHAPIRO
Regulation Number876.5990
Classification Product Code
LNS  
Date Received09/22/2003
Decision Date 02/17/2004
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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