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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 K120335
Device Name EMBRACE THERMOPLASTIC
Original Applicant
BIONIX DEVELOPMENT CORP.
5154 enterprise blvd.
toledo,  OH  43612
Original Contact james huttner m.d., ph.d.
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/08/2012
Decision Date 05/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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