FDA 510(k)

Instrumentos de Cirurgia Geral e Plástica

Número K: K152400 · 2016-01-22

Data da decisão2016-01-22

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

General & Plastic Surgery Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Sontec Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152400. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the General & Plastic Surgery Instruments?

General & Plastic Surgery Instruments is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Sontec Instruments, Inc.. The 510(k) number is K152400.

When did General & Plastic Surgery Instruments receive FDA 510(k) clearance?

General & Plastic Surgery Instruments received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152400.

Who is the listed applicant for General & Plastic Surgery Instruments?

The FDA 510(k) record lists Sontec Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for General & Plastic Surgery Instruments?

The FDA product code for General & Plastic Surgery Instruments is GCJ.

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