FDA 510(k)

Applied Medical Laparoscopic Linear Cutter

Número K: K190331 · 2019-11-22

RequerenteApplied Medical Resources Corporation

Data da decisão2019-11-22

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Applied Medical Laparoscopic Linear Cutter is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K190331. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Applied Medical Laparoscopic Linear Cutter?

Applied Medical Laparoscopic Linear Cutter is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K190331.

When did Applied Medical Laparoscopic Linear Cutter receive FDA 510(k) clearance?

Applied Medical Laparoscopic Linear Cutter received FDA 510(k) clearance on 2019-11-22, under 510(k) number K190331.

Who is the listed applicant for Applied Medical Laparoscopic Linear Cutter?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Applied Medical Laparoscopic Linear Cutter?

The FDA product code for Applied Medical Laparoscopic Linear Cutter is GDW.

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Dispositivos Relacionados (Código: GDW)

Fonte oficial

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