FDA 510(k)

Callaly Tampliner

K号: K211469 · 2021-06-10

决定日期2021-06-10

产品代码HEB

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决定实质等同

器械摘要

Callaly Tampliner is the device name listed in this FDA 510(k) record. The listed applicant is Calla Lily Personal Care, Ltd.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K211469. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Callaly Tampliner?

Callaly Tampliner is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Calla Lily Personal Care, Ltd.. The 510(k) number is K211469.

When did Callaly Tampliner receive FDA 510(k) clearance?

Callaly Tampliner received FDA 510(k) clearance on 2021-06-10, under 510(k) number K211469.

Who is the listed applicant for Callaly Tampliner?

The FDA 510(k) record lists Calla Lily Personal Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Callaly Tampliner?

The FDA product code for Callaly Tampliner is HEB.

列明Calla Lily Personal Care, Ltd.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。

K212304Callaly Tampliner (超级吸收力)K201003Callaly Tampliner

相关器械（代码：HEB）

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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