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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 K984035
Device Name XK-95 HIGH SPEED MOTOR DRILL SYSTEM
Applicant
KOMET MEDICAL
1679 KELLOGG SPRINGS DR.
ATLANTA,  GA  30338
Applicant Contact COURTNEY S PARADICE
Correspondent
KOMET MEDICAL
1679 KELLOGG SPRINGS DR.
ATLANTA,  GA  30338
Correspondent Contact COURTNEY S PARADICE
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/12/1998
Decision Date 06/03/1999
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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