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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 K170442
Device Name Cranial Drill Bits and Accessories
Applicant
Ad-Tech Medical Instrument Corporation
1901 William St.,
Racine,  WI  53404
Applicant Contact Lisa Theama
Correspondent
Quality & Regulatory Associates, LLC
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary J. Syring
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Code
HBG  
Date Received02/14/2017
Decision Date 09/07/2017
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
Recalls CDRH Recalls
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