FDA 510(k)

Tempo 天然卫生棉条

K号: K212272 · 2021-09-17

决定日期2021-09-17

产品代码HEB

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决定实质等同

器械摘要

Tempo Natural Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Dong-A Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K212272. 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 Tempo Natural Tampon?

Tempo Natural Tampon is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Dong-A Pharmaceutical Co., Ltd.. The 510(k) number is K212272.

When did Tempo Natural Tampon receive FDA 510(k) clearance?

Tempo Natural Tampon received FDA 510(k) clearance on 2021-09-17, under 510(k) number K212272.

Who is the listed applicant for Tempo Natural Tampon?

The FDA 510(k) record lists Dong-A Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempo Natural Tampon?

The FDA product code for Tempo Natural Tampon is HEB.

列明Dong-A Pharmaceutical Co., 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。

K212277Tempo 卫生棉条

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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