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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K991625
Device Name KOMET XK-95 PERFORATOR MOTOR (MI-102)
Applicant
KOMET MEDICAL
2188 KNOLL DR.
SAVANNAH,  GA  31419
Applicant Contact COURTNEY S PARADICE
Correspondent
KOMET MEDICAL
2188 KNOLL DR.
SAVANNAH,  GA  31419
Correspondent Contact COURTNEY S PARADICE
Regulation Number882.4370
Classification Product Code
HBB  
Date Received05/11/1999
Decision Date 07/30/1999
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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