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FDA 510(k) Applications Submitted by Spiration, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K162611
09/19/2016
PeriFLEX
SPIRATION, INC.
K170990
04/03/2017
Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator
Spiration, Inc.
K171492
05/22/2017
B7 2C Occlusion Balloon
Spiration, Inc.
K152922
10/02/2015
ViziShot FLEX
SPIRATION, INC.
K142909
10/06/2014
Flexible 19G EBUS Needle
SPIRATION, INC.
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