Durex含苯佐卡因避孕套
K号: K211152 · 2022-05-11
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决定日期2022-05-11
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
Durex Condom with Benzocaine is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K211152. 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 Durex Condom with Benzocaine?
Durex Condom with Benzocaine is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K211152.
When did Durex Condom with Benzocaine receive FDA 510(k) clearance?
Durex Condom with Benzocaine received FDA 510(k) clearance on 2022-05-11, under 510(k) number K211152.
Who is the listed applicant for Durex Condom with Benzocaine?
The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Durex Condom with Benzocaine?
The FDA product code for Durex Condom with Benzocaine is HIS.
相关临床试验
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列明Rb Health (Us), LLC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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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