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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K972308
Device Name MEDNEXT 1000 DRILL
Applicant
Mednext, Inc.
5490 Dexter Way
West Palm Beach,  FL  33407
Applicant Contact THOMAS J MICKEL
Correspondent
Mednext, Inc.
5490 Dexter Way
West Palm Beach,  FL  33407
Correspondent Contact THOMAS J MICKEL
Regulation Number878.4820
Classification Product Code
GEY  
Date Received06/20/1997
Decision Date 08/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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