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510(k) K231058

Hudson RCI® AddiPak® Unit Dose Vial by Medline Industries, LP — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2024
Date Received
April 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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