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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 K030172
Device Name SMALL HIGH SPEED MOTOR DRILL SYSTEM
Applicant
Brasseler USA I, L.P.
4837 Mcgrath St., Suite J
Ventura,  CA  93003
Applicant Contact ANTHONY V ROSE
Correspondent
Brasseler USA I, L.P.
4837 Mcgrath St., Suite J
Ventura,  CA  93003
Correspondent Contact ANTHONY V ROSE
Regulation Number882.4310
Classification Product Code
HBE  
Date Received01/17/2003
Decision Date 04/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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