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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 K063504
Device Name ECONOLITH EM1000
Applicant
Medispec, Ltd.
12850 Middlebrook Rd. Suite 1
Germantown,  MD  20874
Applicant Contact ANIL DHINGRA
Correspondent
Medispec, Ltd.
12850 Middlebrook Rd. Suite 1
Germantown,  MD  20874
Correspondent Contact ANIL DHINGRA
Regulation Number876.5990
Classification Product Code
LNS  
Date Received11/20/2006
Decision Date 03/09/2007
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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