FDA 510(k) Application Details - K163565

Device Classification Name Motor, Drill, Electric

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510(K) Number K163565
Device Name Motor, Drill, Electric
Applicant MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 NORTH BEACH ST.
FORT WORTH, TX 76137 US
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Contact Deep Pal
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 12/19/2016
Decision Date 03/28/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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