FDA 510(k) Applications Submitted by Mallinckrodt Manufacturing LLC

FDA 510(k) Number Submission Date Device Name Applicant
K200389 02/18/2020 INOmax DSIR Plus Mallinckrodt Manufacturing LLC
K211153 04/19/2021 Inomax DSIR Mallinckrodt Manufacturing LLC
K222930 09/26/2022 Evolve Nitric Oxide Delivery System Mallinckrodt Manufacturing LLC
K242578 08/29/2024 EVOLVE Nitric Oxide Delivery System Mallinckrodt Manufacturing LLC


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