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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 K030346
Device Name TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Applicant
Fmd, LLC
P.O.Box 3515
Redmond,  WA  98073
Applicant Contact STEVEN CHERNOFF
Correspondent
Fmd, LLC
P.O.Box 3515
Redmond,  WA  98073
Correspondent Contact STEVEN CHERNOFF
Regulation Number876.5990
Classification Product Code
LNS  
Date Received02/03/2003
Decision Date 05/02/2003
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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