FDA 510(k) Application Details - K163182

Device Classification Name Motor, Drill, Pneumatic

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510(K) Number K163182
Device Name Motor, Drill, Pneumatic
Applicant Medtronic Powered Surgical Solutions
4620 North Beach Street
Fox Worth, TX 76177 US
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Contact Deep Pal
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Regulation Number 882.4370

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Classification Product Code HBB
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Date Received 11/14/2016
Decision Date 03/23/2017
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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