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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Nitric Oxide Delivery
510(k) Number K242578
Device Name EVOLVE Nitric Oxide Delivery System
Applicant
Mallinckrodt Manufacturing, LLC
6603 Femrite Dr.
Madison,  WI  53718
Applicant Contact Jennifer Brett
Correspondent
Mallinckrodt Manufacturing, LLC
6603 Femrite Dr.
Madison,  WI  53718
Correspondent Contact Jennifer Brett
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRP   MRQ  
Date Received08/29/2024
Decision Date 01/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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