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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 Street
Racine,  WI  53404
Applicant Contact Lisa Theama
Correspondent
Quality & Regulatory Associates, LLC
800 Levanger Lane
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
Recalls CDRH Recalls
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