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FDA 510(k)

Agem Ag Mesh Dressing with Silver

K 號：K152544 · 2016-05-23

申請人Shenzhen Yuanxing Nano-Pharma Co., Ltd.
決定日期2016-05-23
產品代碼FRO
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械（代碼：FRO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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