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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 K983092
Device Name TRITON HUDSON CHUCK ATTACHMENT
Applicant
Mednext, Inc.
5490 Dexter Way
West Palm Beach,  FL  33407
Applicant Contact STEWART WILLASON
Correspondent
Mednext, Inc.
5490 Dexter Way
West Palm Beach,  FL  33407
Correspondent Contact STEWART WILLASON
Regulation Number882.4370
Classification Product Code
HBB  
Date Received09/03/1998
Decision Date 11/06/1998
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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