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FDA 510(k) Applications Submitted by PATTI L ARNDT
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171358
05/09/2017
Emprint SX Ablation Platform and Accessories
Coviden llc
K141938
07/17/2014
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
TERUMO BCT, INC..
K103090
10/19/2010
SPECTRA OPTIA R APHERESIS SYSTEM
CARIDIANBCT, INC.
K163105
11/07/2016
Emprint Ablation System
COVIDIEN LLC
K071079
04/17/2007
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
GAMBRO BCT, INC.
K180192
01/24/2018
Emprint Ablation Visualization Application
Covidien, LLC
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