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FDA 510(k)

Endoform Silver Dermal Template

K号: K172318 · 2017-11-17

决定日期2017-11-17
产品代码FRO
决定实质等同

器械摘要

Endoform Silver Dermal Template is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172318. 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 Endoform Silver Dermal Template?

Endoform Silver Dermal Template is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Aroa Biosurgery. The 510(k) number is K172318.

When did Endoform Silver Dermal Template receive FDA 510(k) clearance?

Endoform Silver Dermal Template received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172318.

Who is the listed applicant for Endoform Silver Dermal Template?

The FDA 510(k) record lists Aroa Biosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoform Silver Dermal Template?

The FDA product code for Endoform Silver Dermal Template is FRO. This falls under the Anesthesiology category.

相关临床试验

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列明Aroa Biosurgery为申报人的其他记录

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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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