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FDA 510(k) Applications Submitted by MARY ANNE PATELLA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180086
01/12/2018
Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter
Gyrus ACMI, Inc.
K190164
01/31/2019
CleverLock Guidewire Locking Device and Biopsy Cap
Olympus Surgical Technologies America
K171232
04/27/2017
PeriView FLEX
Olympus Surgical Technologies America
K181193
05/04/2018
PeriView FLEX
Olympus Surgical Technologies America
K163469
12/12/2016
ViziShot 2 FLEX
Olympus Surgical Technologies America
K143609
12/19/2014
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
K193517
12/19/2019
ViziShot 2 FLEX
Olympus Surgical Technologies America
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