FDA 510(k) Applications for Medical Device Product Code "PLP"

FDA 510(k) Number Applicant Device Name Decision Date
K172285 EDAP TECHNOMED, INC. Ablatherm Fusion 10/03/2017
K153023 EDAP TECHNOMED, INC. Ablatherm Integrated Imaging 11/06/2015
K172721 EDAP Technomed, Inc. FOCAL ONE 06/07/2018
K160942 SonaCare Medical, LLC Sonablate 12/21/2016
DEN150011 SonaCare Medical, LLC. Sonablate 450 10/09/2015


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