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FDA 510(k)

抗菌敷料

K号: K200821 · 2020-10-19

决定日期2020-10-19
产品代码FRO
决定实质等同

器械摘要

anti-bacterial bandage is the device name listed in this FDA 510(k) record. The listed applicant is Planet (Suzhou) Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K200821. 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.

常见问题

What is the anti-bacterial bandage?

anti-bacterial bandage is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Planet (Suzhou) Medical Products Co., Ltd.. The 510(k) number is K200821.

When did anti-bacterial bandage receive FDA 510(k) clearance?

anti-bacterial bandage received FDA 510(k) clearance on 2020-10-19, under 510(k) number K200821.

Who is the listed applicant for anti-bacterial bandage?

The FDA 510(k) record lists Planet (Suzhou) Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for anti-bacterial bandage?

The FDA product code for anti-bacterial bandage is FRO. This falls under the Anesthesiology category.

相关临床试验

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相关器械(代码:FRO)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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