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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 K222930
Device Name Evolve Nitric Oxide Delivery System
Applicant
Mallinckrodt Manufacturing LLC
6603 Femrite Drive
Madison,  WI  53718
Applicant Contact David Trueblood
Correspondent
Mallinckrodt Hospital Products Inc.
Shelbourne Building, 53 Frontage Rd Suite 300
Hampton,  NJ  08827
Correspondent Contact David Trueblood
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRP   MRQ  
Date Received09/26/2022
Decision Date 12/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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