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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K220565
Device Name Hudson RCI Triflo II Incentive Deep Breathing Exerciser
Applicant
Medline Industries, Inc.
1 Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Nicole Schaffer
Correspondent
RQM+
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Joy Gutermuth
Regulation Number868.5690
Classification Product Code
BWF  
Date Received02/28/2022
Decision Date 10/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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