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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 K201728
Device Name Versalock Periprosthetic Femur Plates System-GMReis
Applicant
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De La Place 600
Campinas,  BR 13069320
Applicant Contact Paula Oliveira
Correspondent
Pr Servicos Regulatorios Administrativos Ltda
Rua Alice Alem Saadi, 855/2402
Ribeirao Preto,  BR 14096-570
Correspondent Contact Janine Treter
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDP   JDQ  
Date Received06/23/2020
Decision Date 03/08/2021
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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