FDA 510(k)

Astroglide Organix 液体

K号: K200114 · 2020-10-13

决定日期2020-10-13

产品代码NUC

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决定实质等同

器械摘要

Astroglide Organix Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2020-10-13 under 510(k) number K200114. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Astroglide Organix Liquid?

Astroglide Organix Liquid is a medical device that received FDA 510(k) clearance on 2020-10-13. The listed applicant is Biofilm, Inc.. The 510(k) number is K200114.

When did Astroglide Organix Liquid receive FDA 510(k) clearance?

Astroglide Organix Liquid received FDA 510(k) clearance on 2020-10-13, under 510(k) number K200114.

Who is the listed applicant for Astroglide Organix Liquid?

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

What is the FDA product code for Astroglide Organix Liquid?

The FDA product code for Astroglide Organix Liquid is NUC.

列明Biofilm, 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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