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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 K213454
Device Name Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
Applicant
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact Carrie Eddings
Correspondent
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Correspondent Contact Carrie Eddings
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Codes
HBB   HBC  
Date Received10/26/2021
Decision Date 11/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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