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FDA 510(k)

Agem Ag Mesh Dressing with Silver

K-Number: K152544 · 2016-05-23

ApplicantShenzhen Yuanxing Nano-Pharma Co., Ltd.
Decision Date2016-05-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Agem Ag Mesh Dressing with Silver is a medical device manufactured by Shenzhen Yuanxing Nano-Pharma Co., Ltd.. It received FDA 510(k) clearance on 2016-05-23 under approval 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.

Frequently Asked Questions

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. It is manufactured by Shenzhen Yuanxing Nano-Pharma Co., Ltd.. The 510(k) number is K152544.

When was Agem Ag Mesh Dressing with Silver approved by the FDA?

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

What company makes Agem Ag Mesh Dressing with Silver?

Agem Ag Mesh Dressing with Silver is manufactured by Shenzhen Yuanxing Nano-Pharma Co., Ltd..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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