FDA 510(k)

含苯佐卡因的One Touch安全套

K号: K171213 · 2018-01-12

申请人Thai Nippon Rubber Industry Public Company Limited.

决定日期2018-01-12

产品代码HIS

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决定实质等同

器械摘要

One Touch Condom with Benzocaine is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171213. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the One Touch Condom with Benzocaine?

One Touch Condom with Benzocaine is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K171213.

When did One Touch Condom with Benzocaine receive FDA 510(k) clearance?

One Touch Condom with Benzocaine received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171213.

Who is the listed applicant for One Touch Condom with Benzocaine?

The FDA 510(k) record lists Thai Nippon Rubber Industry Public Company Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Touch Condom with Benzocaine?

The FDA product code for One Touch Condom with Benzocaine is HIS.

列明Thai Nippon Rubber Industry Public Company 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。

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相关器械（代码：HIS）

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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