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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K162559
Device Name Move Forward 3D Motion Simulation Service
Applicant
BIOMET INC.
56 EAST BELL DRIVE
warsaw,  IN  46581
Applicant Contact paul hardy
Correspondent
BIOMET INC.
56 EAST BELL DRIVE
warsaw,  IN  46581
Correspondent Contact paul hardy
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/14/2016
Decision Date 03/31/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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