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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 K121656
Device Name GEMINI LITHOTRIPTER
Applicant
DORNIER MEDTECH AMERICA, INC.
1155 ROBERTS BLVD.
KENNESAW,  GA  30144
Applicant Contact JOHN HOFFER
Correspondent
DORNIER MEDTECH AMERICA, INC.
1155 ROBERTS BLVD.
KENNESAW,  GA  30144
Correspondent Contact JOHN HOFFER
Regulation Number876.5990
Classification Product Code
LNS  
Date Received06/05/2012
Decision Date 09/24/2012
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
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