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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