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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
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