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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K143365
Device Name Eminent Foot Plate System
Applicant
Eminent Spine
7200 N. Ih 35 Bldg. #1
Georgetown,  TX  78626
Applicant Contact Dave Freehill
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/24/2014
Decision Date 03/30/2015
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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