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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
K212150
Insightec, Inc
Exablate Prostate System
11/23/2021
K202286
Profound Medical Inc
Tulsa-Pro System
09/16/2020
K211858
Profound Medical Inc.
TULSA-PRO System
09/06/2022
K191200
PROFOUND MEDICAL INC.
TULSA-PRO System
08/15/2019
K230692
Profound Medical Inc.
TULSA-PRO System
09/20/2023
K160942
SonaCare Medical, LLC
Sonablate
12/21/2016
DEN150011
SonaCare Medical, LLC.
Sonablate 450
10/09/2015
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