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FDA 510(k) Applications Submitted by Aditi Kolla
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190719
03/20/2019
Artemis Eye System
Penumbra, Inc.
K170852
03/22/2017
POD Packing Coil
Penumbra, Inc.
K161523
06/02/2016
INDIGO Aspiration System
Penumbra, Inc.
K173614
11/22/2017
Penumbra Coil 400, Ruby Coil System, POD System
Penumbra, Inc.
K203440
11/23/2020
Penumbra System (Reperfusion Catheter RED 62)
Penumbra, Inc.
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