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FDA 510(k) Applications Submitted by Duane Gutowski
FDA 510(k) Number
Submission Date
Device Name
Applicant
K201373
05/26/2020
DRX-Compass
Carestream Health, Inc
K191879
07/15/2019
DRX-Evolution with Carestream Digital Tomosynthesis
Carestream Health, Inc.
K202441
08/26/2020
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
K192894
10/11/2019
Vita Flex CR System with LLI
Carestream Health, Inc.
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