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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K031687
Device Name VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
Applicant
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Applicant Contact HEATHER CRAWFORD
Correspondent
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Correspondent Contact HEATHER CRAWFORD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/02/2003
Decision Date 04/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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