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510(k) K231684

Device
Quick - Radius Disposable Set
Applicant
GM Dos Reis Industria e Comercio Ltda.
510(k) number
K231684
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-12
Date received
2023-06-09
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Guilherme Esteves Pontes
Address
Avenida Pierre Simon De La Pl. 600 Campinas BR 13069-320 13069-320

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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