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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 K160942
Device Name Sonablate
Applicant
SonaCare Medical, LLC
10130 PERIMETER PARKWAY, SUITE 250
CHARLOTTE,  NC  28216
Applicant Contact DAVID M. HERNON
Correspondent
SONACARE MEDICAL, LLC
10130 PERIMETER PARKWAY, SUITE 250
CHARLOTTE,  NC  28216
Correspondent Contact DAVID M. HERNON
Regulation Number876.4340
Classification Product Code
PLP  
Date Received04/05/2016
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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