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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K874535
Device Name MICROTEK MINI-MAX DRILL SYSTEM
Applicant
Microtek Medical, Inc.
Post Office Box 2487
Columbus,  MS  39704
Applicant Contact KEITH MCGEE
Correspondent
Microtek Medical, Inc.
Post Office Box 2487
Columbus,  MS  39704
Correspondent Contact KEITH MCGEE
Regulation Number872.4120
Classification Product Code
DZI  
Date Received11/03/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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