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FDA 510(k) Applications Submitted by Koelis
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100793
03/22/2010
UROSTATION 3D PROSTATE SUITE
KOELIS
K160357
02/08/2016
TRINITY
KOELIS
K170521
02/22/2017
TRINITY/3D PROSTATE SUITE
KOELIS
K171040
04/06/2017
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
Koelis
K131448
05/20/2013
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
KOELIS
K141334
05/21/2014
REUSABLE GUIDE
KOELIS
K180970
04/13/2018
Disposable guides KDNG00
Koelis
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