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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K112094
Device Name BRAIN BIOPSY NEEDLE
Applicant
AD-TECH MEDICAL INSTRUMENT CORP.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary J Syring
Correspondent
AD-TECH MEDICAL INSTRUMENT CORP.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary J Syring
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
FCG  
Date Received07/22/2011
Decision Date 04/24/2012
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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