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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 K101482
Device Name EM-9000
Applicant
Elite Medical, Inc.
4343 Shallowford Rd.
Suite H-4b Marietta
Atlanta,  GA  30062
Applicant Contact STEVEN J DE BROCK
Correspondent
Elite Medical, Inc.
4343 Shallowford Rd.
Suite H-4b Marietta
Atlanta,  GA  30062
Correspondent Contact STEVEN J DE BROCK
Regulation Number876.5990
Classification Product Code
LNS  
Date Received05/28/2010
Decision Date 03/31/2011
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
Predetermined Change
Control Plan Authorized		 No
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