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FDA 510(k) Applications Submitted by Leena Sorathia
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190525
03/04/2019
RELIEVA ULTIRRA Sinus Balloon Catheter
Acclarent, Inc.
K190532
03/04/2019
TruDi NAV Wire
Acclarent, Inc.
K180948
04/11/2018
TruDi NAV Suction Instruments
Acclarent, Inc.
K201174
05/01/2020
TruDi Curette
Acclarent, Inc.
K183090
11/06/2018
Relieva Tract Balloon Dilation System
Acclarent, Inc.
K193453
12/13/2019
TruDi Probe
Acclarent, Inc.
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