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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 Dr.
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
Predetermined Change
Control Plan Authorized		 No
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