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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress And Bed Deck Cover (Medical Purposes)
510(k) Number K201876
Device Name Soteria Bed Barrier
Applicant
Trinity Guardion
4 S Park Ave. Suite 204
Batesville,  IN  47006
Applicant Contact Bruce Rippe
Correspondent
Trinity Guardion
4 S Park Ave. Suite 204
Batesville,  IN  47006
Correspondent Contact Bruce Rippe
Regulation Number880.6190
Classification Product Code
QTV  
Date Received07/07/2020
Decision Date 09/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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