FDA 510(k)

Premium 冷却个人润滑剂，Premium 肛门冷却润滑剂

K号: K200602 · 2020-06-03

决定日期2020-06-03

产品代码NUC

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决定实质等同

器械摘要

Premium Cooling Personal Lubricant, Premium Anal Cooling 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 2020-06-03 under 510(k) number K200602. 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 Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is CC Wellness, LLC. The 510(k) number is K200602.

When did Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant receive FDA 510(k) clearance?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200602.

Who is the listed applicant for Premium Cooling Personal Lubricant, Premium Anal Cooling 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 Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

The FDA product code for Premium Cooling Personal Lubricant, Premium Anal Cooling 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 K221908JO CUMPLAY 个人润滑剂 K212885Actively Trying 个人润滑剂玫瑰香型 K212705Actively Trying 个人润滑剂无香型

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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。