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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K231058
Device Name Hudson RCI® AddiPak® Unit Dose Vial
Applicant
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Phyllis Kondor
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Phyllis Kondor
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/13/2023
Decision Date 01/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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