FDA 510(k)

Playboy 3 凸面避孕套

K号: K211450 · 2021-09-30

申请人Thai Nippon Rubber Industry Public Company Limited.

决定日期2021-09-30

产品代码HIS

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决定实质等同

器械摘要

Playboy 3 Contour Condom 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 2021-09-30 under 510(k) number K211450. 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 Playboy 3 Contour Condom?

Playboy 3 Contour Condom is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K211450.

When did Playboy 3 Contour Condom receive FDA 510(k) clearance?

Playboy 3 Contour Condom received FDA 510(k) clearance on 2021-09-30, under 510(k) number K211450.

Who is the listed applicant for Playboy 3 Contour Condom?

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 Playboy 3 Contour Condom?

The FDA product code for Playboy 3 Contour Condom 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。

K220273Onetouch 非对羟基苯甲酸酯润滑凝胶 K210095Playboy 高级硅胶润滑剂 K210294One Touch螺旋安全套 K171213含苯佐卡因的One Touch安全套

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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