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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 K140098
Device Name EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
Applicant
Emerge Medical
4628 Northpark Dr.
Attn: Empirical Consulting
Colorado Springs,  CO  80918
Applicant Contact MEREDITH MAY MS, RAC
Correspondent
Emerge Medical
4628 Northpark Dr.
Attn: Empirical Consulting
Colorado Springs,  CO  80918
Correspondent Contact MEREDITH MAY MS, RAC
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/14/2014
Decision Date 03/12/2014
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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