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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K141347
Device Name EMERGE MEDICAL IM NAIL SYSTEM
Applicant
Emerge Medical
720 S. Colorado Blvd.
Suite 550-S
Denver,  CO  80246
Applicant Contact MICHELLE POTVIN
Correspondent
Emerge Medical
720 S. Colorado Blvd.
Suite 550-S
Denver,  CO  80246
Correspondent Contact MICHELLE POTVIN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/22/2014
Decision Date 10/02/2014
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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