FDA 510(k)

Dermapose Access

K号: K200168 · 2020-04-22

决定日期2020-04-22

产品代码QPB

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决定实质等同

器械摘要

Dermapose Access is the device name listed in this FDA 510(k) record. The listed applicant is Puregraft, LLC. It received FDA 510(k) clearance on 2020-04-22 under 510(k) number K200168. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dermapose Access?

Dermapose Access is a medical device that received FDA 510(k) clearance on 2020-04-22. The listed applicant is Puregraft, LLC. The 510(k) number is K200168.

When did Dermapose Access receive FDA 510(k) clearance?

Dermapose Access received FDA 510(k) clearance on 2020-04-22, under 510(k) number K200168.

Who is the listed applicant for Dermapose Access?

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

What is the FDA product code for Dermapose Access?

The FDA product code for Dermapose Access is QPB.

列明Puregraft, LLC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。

K193363Dermapose Refresh

官方来源

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