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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 K935861
Device Name MEDNEXT BUR
Applicant
Mednext, Inc.
3878 Prospect Ave., Suite 24
West Point Beach,  FL  33404
Applicant Contact THOMAS J MICKEL
Correspondent
Mednext, Inc.
3878 Prospect Ave., Suite 24
West Point Beach,  FL  33404
Correspondent Contact THOMAS J MICKEL
Regulation Number882.4310
Classification Product Code
HBE  
Date Received12/03/1993
Decision Date 05/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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