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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 K172084
Device Name Delta III Lithotripter
Applicant
Dornier Medtech America, Inc.
1155 Roberts Blvd., Suite 100
Kennesaw,  GA  30144
Applicant Contact John Hoffer
Correspondent
Dornier Medtech America, Inc.
1155 Roberts Blvd., Suite 100
Kennesaw,  GA  30144
Correspondent Contact John Hoffer
Regulation Number876.5990
Classification Product Code
LNS  
Date Received07/10/2017
Decision Date 08/08/2017
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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