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510(k) K163565

MR8 Drill System by Medtronic Powered Surgical Solutions — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2017
Date Received
December 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

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