FDA 510(k)

Agem Ag Mesh Dressing with Silver

Número K: K152544 · 2016-05-23

RequerenteShenzhen Yuanxing Nano-Pharma Co., Ltd.

Data da decisão2016-05-23

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Agem Ag Mesh Dressing with Silver is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yuanxing Nano-Pharma Co., Ltd.. It received FDA 510(k) clearance on 2016-05-23 under 510(k) number K152544. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Agem Ag Mesh Dressing with Silver?

Agem Ag Mesh Dressing with Silver is a medical device that received FDA 510(k) clearance on 2016-05-23. The listed applicant is Shenzhen Yuanxing Nano-Pharma Co., Ltd.. The 510(k) number is K152544.

When did Agem Ag Mesh Dressing with Silver receive FDA 510(k) clearance?

Agem Ag Mesh Dressing with Silver received FDA 510(k) clearance on 2016-05-23, under 510(k) number K152544.

Who is the listed applicant for Agem Ag Mesh Dressing with Silver?

The FDA 510(k) record lists Shenzhen Yuanxing Nano-Pharma Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agem Ag Mesh Dressing with Silver?

The FDA product code for Agem Ag Mesh Dressing with Silver is FRO. This falls under the Anesthesiology category.

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