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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 K130729
Device Name EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
Applicant
Dornier Medtech Systems
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact JOHN HOFFER
Correspondent
Dornier Medtech Systems
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact JOHN HOFFER
Regulation Number876.5990
Classification Product Code
LNS  
Date Received03/18/2013
Decision Date 05/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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