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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 K131480
Device Name EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
Applicant
Emerge Medical
790 S. Colorado Blvd.
Suite 550-S
Denver,  CO  80246
Applicant Contact VICTORIA TRAFKA
Correspondent
Emerge Medical
790 S. Colorado Blvd.
Suite 550-S
Denver,  CO  80246
Correspondent Contact VICTORIA TRAFKA
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/22/2013
Decision Date 07/03/2013
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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