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FDA 510(k)

Play&Joy InvisiLube 润滑剂胶囊

K号: K220646 · 2023-07-10

决定日期2023-07-10
产品代码NUC
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

Play&Joy InvisiLube Lubricant Capsule is the device name listed in this FDA 510(k) record. The listed applicant is Innovemed Bio-Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-07-10 under 510(k) number K220646. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Play&Joy InvisiLube Lubricant Capsule?

Play&Joy InvisiLube Lubricant Capsule is a medical device that received FDA 510(k) clearance on 2023-07-10. The listed applicant is Innovemed Bio-Tech Co., Ltd.. The 510(k) number is K220646.

When did Play&Joy InvisiLube Lubricant Capsule receive FDA 510(k) clearance?

Play&Joy InvisiLube Lubricant Capsule received FDA 510(k) clearance on 2023-07-10, under 510(k) number K220646.

Who is the listed applicant for Play&Joy InvisiLube Lubricant Capsule?

The FDA 510(k) record lists Innovemed Bio-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Play&Joy InvisiLube Lubricant Capsule?

The FDA product code for Play&Joy InvisiLube Lubricant Capsule is NUC.

相关临床试验

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列明Innovemed Bio-Tech Co., Ltd.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:NUC)

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。

官方来源

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