EXPERT - Joint Fixation System

Washer, Bolt Nut

GM Dos Reis Industria E Comercio Ltda

The following data is part of a premarket notification filed by Gm Dos Reis Industria E Comercio Ltda with the FDA for Expert - Joint Fixation System.

Pre-market Notification Details

Device IDK200332
510k NumberK200332
Device Name:EXPERT - Joint Fixation System
ClassificationWasher, Bolt Nut
Applicant GM Dos Reis Industria E Comercio Ltda Avenida Pierre Simon De La Place 600 Campinas,  BR 13069320
ContactPaula Oliveira
CorrespondentGraziela Brum
PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto,  BR 14096-570
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-10
Decision Date2020-10-29

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