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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K153270
Device Name TruGuard Custom Tongue and Jaw Positioner
Applicant
Bionix Development Corp.
5154 Enterprise Blvd.
Toledo,  OH  43612
Applicant Contact JAMES HUTTNER
Correspondent
Bionix Development Corp.
5154 Enterprise Blvd.
Toledo,  OH  43612
Correspondent Contact JAMES HUTTNER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/12/2015
Decision Date 03/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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