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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Ultrasonic
510(k) Number K181364
Device Name Swiss LithoClast Trilogy
Applicant
E.M.S Electro Medical Systems S.A
Ch De La Vuarpilliere
Nyon,  CH 1260
Applicant Contact Sonia Callegaro
Correspondent
Heyer Regulatory Solutions, LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number876.4480
Classification Product Code
FEO  
Subsequent Product Code
FFK  
Date Received05/23/2018
Decision Date 06/20/2018
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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