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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 K062081
Device Name LITHOGOLD
Applicant
TISSUE REGENERATION TECHNOLOGIES, INC.
719 A ST., NE
WASHINGTON,  DC  20002
Applicant Contact CHERITA JAMES
Correspondent
TISSUE REGENERATION TECHNOLOGIES, INC.
719 A ST., NE
WASHINGTON,  DC  20002
Correspondent Contact CHERITA JAMES
Regulation Number876.5990
Classification Product Code
LNS  
Date Received07/21/2006
Decision Date 11/02/2006
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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