FDA 510(k)

Elegant 2 in 1 阴道保湿剂，Elegant Advanced 5

K号: K201612 · 2021-09-02

决定日期2021-09-02

产品代码NUC

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 is the device name listed in this FDA 510(k) record. The listed applicant is Viramal Limited. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K201612. 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 Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5?

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Viramal Limited. The 510(k) number is K201612.

When did Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 receive FDA 510(k) clearance?

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 received FDA 510(k) clearance on 2021-09-02, under 510(k) number K201612.

Who is the listed applicant for Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5?

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

What is the FDA product code for Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5?

The FDA product code for Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 is NUC.

列明Viramal Limited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。

K231794Elegant™ 高级 CompHort

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。