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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drills, burrs, trephines & accessories (simple, powered)
510(k) Number K121264
Model ED500
Device Name TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
Original Applicant
MEDTRONIC SURGICAL TECHNOLOGIES
4620 north beach street
fort worth,  TX  76137
Original Contact rishi sinha
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Codes
HBC   HRX   HWE  
Date Received04/26/2012
Decision Date 08/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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