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FDA 510(k) Applications Submitted by KATHY O'SHAUGHNESSY
FDA 510(k) Number
Submission Date
Device Name
Applicant
K040028
01/08/2004
CA-1500
R2 TECHNOLOGY, INC.
K160141
01/21/2016
miraDry System
Miramar Labs, Inc.
K150419
02/18/2015
miraDry System MD4000
MIRAMAR LABS, INC.
DEN220014
02/23/2022
RefleXion Medical Radiotherapy System (RMRS)
RefleXion Medical Inc
K050843
04/01/2005
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
XOFT, INC.
K131162
04/24/2013
MIRADRY SYSTEM
MIRAMAR LABS, INC.
K041380
05/25/2004
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
R2 TECHNOLOGY, INC.
K023003
09/09/2002
IMAGECHECKER-CT WORKSTATION
R2 TECHNOLOGY, INC.
K082819
09/25/2008
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
MIRAMAR LABS, INC.
K103014
10/13/2010
MIRADRY SYSTEM
MIRAMAR LABS, INC.
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