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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 K220955
Device Name Hudson RCI Variable concentration Large Volume Nebulizer (1770)
Medline Industires, Inc.
1 Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Nicole Schaffer
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Joy Gutermuth
Regulation Number868.5630
Classification Product Code
Date Received04/01/2022
Decision Date 06/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No