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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
Predetermined Change
Control Plan Authorized		 No
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