男性乳胶避孕套
K号: K162919 · 2017-03-07
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决定日期2017-03-07
产品代码HIS
咨询委员会OB
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决定实质等同
器械摘要
Male Latex Condoms is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Xiangban Latex Products Co., Ltd.. It received FDA 510(k) clearance on 2017-03-07 under 510(k) number K162919. 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 Male Latex Condoms?
Male Latex Condoms is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Zhejiang Xiangban Latex Products Co., Ltd.. The 510(k) number is K162919.
When did Male Latex Condoms receive FDA 510(k) clearance?
Male Latex Condoms received FDA 510(k) clearance on 2017-03-07, under 510(k) number K162919.
Who is the listed applicant for Male Latex Condoms?
The FDA 510(k) record lists Zhejiang Xiangban Latex Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Male Latex Condoms?
The FDA product code for Male Latex Condoms is HIS.
相关临床试验
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。
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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