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510(k) K130755

HICUT HIGHSPEED INSTRUMENT by Adeor Medical AG — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2014
Date Received
March 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

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