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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
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