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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K153211
Device Name M-Fix Acromioclavicular Device
Applicant
Coracoid Solutions, Inc.
15 Normans Way
Park City,  UT  84060
Applicant Contact STEVE GOLDEN
Correspondent
Michael Kolber
337 Ester Ave.
Campbell,  CA  94025
Correspondent Contact MICHAEL KOLBER
Regulation Number888.3030
Classification Product Code
HTN  
Date Received11/05/2015
Decision Date 02/02/2016
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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