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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K220514
Device Name bite away neo
Applicant
Mibetec, GmbH
Munchener Strasse 15
Brehna,  DE D-06796
Applicant Contact Oliver Grunert
Correspondent
QSR Consulting
10807 Dakota Ranch Rd.
Santee,  CA  92071
Correspondent Contact Kenneth Kleinhenz
Regulation Number890.5740
Classification Product Code
IRT  
Date Received02/22/2022
Decision Date 06/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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