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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 K162635
Device Name Distal Radius Plating System
Applicant
Miami Device Solutions, LLC
7620 NW 25th St., Unit 3
Miami,  FL  33122
Applicant Contact Michelle Montesino
Correspondent
Miami Device Solutions, LLC
7620 NW 25th St., Unit 3
Miami,  FL  33122
Correspondent Contact Michelle Montesino
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/21/2016
Decision Date 10/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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