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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K092033
Device Name VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
Applicant
ELMED USA
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact JONATHAN WARD
Correspondent
ELMED USA
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact JONATHAN WARD
Regulation Number876.4480
Classification Product Code
FFK  
Date Received07/06/2009
Decision Date 04/30/2010
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
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