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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 K172721
Device Name FOCAL ONE
Applicant
EDAP Technomed, Inc.
5321 Industrial Oaks Blvd, Suite 110
AUSTIN,  TX  78735
Applicant Contact Hugo Embert
Correspondent
EDAP Technomed, Inc.
5321 Industrial Oaks Blvd, Suite 110
AUSTIN,  TX  78735
Correspondent Contact Hugo Embert
Regulation Number876.4340
Classification Product Code
PLP  
Date Received09/08/2017
Decision Date 06/07/2018
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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