FDA 510(k)

Algidex Ag 硅藻土伤口敷料

K号: K173072 · 2018-04-04

决定日期2018-04-04

产品代码FRO

决定实质等同

器械摘要

Algidex Ag Silver Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K173072. 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 Algidex Ag Silver Alginate Wound Dressing?

Algidex Ag Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K173072.

When did Algidex Ag Silver Alginate Wound Dressing receive FDA 510(k) clearance?

Algidex Ag Silver Alginate Wound Dressing received FDA 510(k) clearance on 2018-04-04, under 510(k) number K173072.

Who is the listed applicant for Algidex Ag Silver Alginate Wound Dressing?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Algidex Ag Silver Alginate Wound Dressing?

The FDA product code for Algidex Ag Silver Alginate Wound Dressing is FRO. This falls under the Anesthesiology category.

列明Deroyal Industries, Inc.为申报人的其他记录

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。

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