FDA 510(k)

JO CUMPLAY 个人润滑剂

K号: K221908 · 2022-09-20

决定日期2022-09-20

产品代码NUC

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决定实质等同

器械摘要

JO CUMPLAY Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is CC Wellness, LLC. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K221908. 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 JO CUMPLAY Personal Lubricant?

JO CUMPLAY Personal Lubricant is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is CC Wellness, LLC. The 510(k) number is K221908.

When did JO CUMPLAY Personal Lubricant receive FDA 510(k) clearance?

JO CUMPLAY Personal Lubricant received FDA 510(k) clearance on 2022-09-20, under 510(k) number K221908.

Who is the listed applicant for JO CUMPLAY Personal Lubricant?

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

What is the FDA product code for JO CUMPLAY Personal Lubricant?

The FDA product code for JO CUMPLAY Personal Lubricant is NUC.

列明CC Wellness, 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。

K232091JO 椰子混合冷却个人润滑剂 K232090JO 椰子混合加热个人润滑剂 K230674JO 水基肛门浓稠润滑剂 2oz 型号 40112，JO 水基肛门浓稠润滑剂 4oz 型号 40112，JO 水基肛门浓稠润滑剂 8oz 型号 40114 K212885Actively Trying 个人润滑剂玫瑰香型 K212705Actively Trying 个人润滑剂无香型 K210986H2O 冷却个人润滑剂，H2O 分析冷却个人润滑剂，#LubeLife Sensations 冷却，#LubeLife Sensations 双人愉悦套装，JO 2 To Tango for Me，JO 2 To Tango 双人愉悦套装

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官方来源

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