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FDA 510(k)

Royal Condoms (天然、黑葡萄、咖啡、草莓和巧克力口味)

K号: K161195 · 2016-08-25

申请人M3 Global Enterprises, LLC
决定日期2016-08-25
产品代码HIS
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

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is the device name listed in this FDA 510(k) record. The listed applicant is M3 Global Enterprises, LLC. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161195. 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 Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is M3 Global Enterprises, LLC. The 510(k) number is K161195.

When did Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) receive FDA 510(k) clearance?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161195.

Who is the listed applicant for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

The FDA 510(k) record lists M3 Global Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

The FDA product code for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is HIS.

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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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官方来源

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