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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Intensity Ultrasound System For Prostate Tissue Ablation
510(k) Number K153023
Device Name Ablatherm Integrated Imaging
Applicant
Edap Technomed, Inc.
2201 Denton Dr., Suite 110
Austin,  TX  78758
Applicant Contact MARC OCZACHOWSKI
Correspondent
Edap Technomed, Inc.
2201 Denton Dr., Suite 110
Austin,  TX  78758
Correspondent Contact JOHN C REWCASTLE
Regulation Number876.4340
Classification Product Code
PLP  
Date Received10/15/2015
Decision Date 11/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00295802
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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