FDA 510(k)

TECHFIT Patient-Specific Maxillofacial System

Número K: K203282 · 2021-05-19

RequerenteIndustrias Medicas Sampedro S.A.S

Data da decisão2021-05-19

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TECHFIT Patient-Specific Maxillofacial System is the device name listed in this FDA 510(k) record. The listed applicant is Industrias Medicas Sampedro S.A.S. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K203282. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TECHFIT Patient-Specific Maxillofacial System?

TECHFIT Patient-Specific Maxillofacial System is a medical device that received FDA 510(k) clearance on 2021-05-19. The listed applicant is Industrias Medicas Sampedro S.A.S. The 510(k) number is K203282.

When did TECHFIT Patient-Specific Maxillofacial System receive FDA 510(k) clearance?

TECHFIT Patient-Specific Maxillofacial System received FDA 510(k) clearance on 2021-05-19, under 510(k) number K203282.

Who is the listed applicant for TECHFIT Patient-Specific Maxillofacial System?

The FDA 510(k) record lists Industrias Medicas Sampedro S.A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHFIT Patient-Specific Maxillofacial System?

The FDA product code for TECHFIT Patient-Specific Maxillofacial System is JEY.

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Fonte oficial

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