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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 K130755
Device Name HICUT HIGHSPEED INSTRUMENT
Applicant
Adeor Medical AG
Kirchplatz 1
Pullach,  DE 82049
Applicant Contact FABIO VON ZEPPELIN
Correspondent
Adeor Medical AG
Kirchplatz 1
Pullach,  DE 82049
Correspondent Contact FABIO VON ZEPPELIN
Regulation Number882.4310
Classification Product Code
HBE  
Date Received03/19/2013
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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