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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 K250047
Device Name bite away two
Applicant
mibeTec GmbH
Münchener St. 15
Brehna,  DE 06796
Applicant Contact Oliver Grunert
Correspondent
mibeTec GmbH
Münchener St. 15
Brehna,  DE 06796
Correspondent Contact Oliver Grunert
Regulation Number890.5740
Classification Product Code
IRT  
Date Received01/10/2025
Decision Date 09/12/2025
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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