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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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