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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 K042427
Device Name GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Applicant
Genemed, Inc.
660 Main St. S.
Suite 7
Woodbury,  CT  06798
Applicant Contact DAVID BALZER
Correspondent
Genemed, Inc.
660 Main St. S.
Suite 7
Woodbury,  CT  06798
Correspondent Contact DAVID BALZER
Regulation Number876.5990
Classification Product Code
LNS  
Date Received09/08/2004
Decision Date 12/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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