FDA 510(k) Applications Submitted by Michael Mach

FDA 510(k) Number Submission Date Device Name Applicant
K061791 06/26/2006 FOCUS VNG/ENG TYPE 1068 GN OTOMETRICS A/S
K192396 09/03/2019 Streamline MIS Spinal Fixation System Pioneer Surgical Technology, Inc.
K213818 12/07/2021 VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula Covidien


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