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510(k) K163182

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories by Medtronic Powered Surgical Solutions — Product Code HBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2017
Date Received
November 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

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