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FDA 510(k)

Premium 加热个人润滑剂，Premium 肛门加热润滑剂，全能加热

K号: K200457 · 2020-05-22

申请人CC Wellness, LLC
决定日期2020-05-22
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

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming 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 2020-05-22 under 510(k) number K200457. 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 Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is CC Wellness, LLC. The 510(k) number is K200457.

When did Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming receive FDA 510(k) clearance?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming received FDA 510(k) clearance on 2020-05-22, under 510(k) number K200457.

Who is the listed applicant for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

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 Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

The FDA product code for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is NUC.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 40114K221908JO 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

查看所有 12 个设备 →

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。

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm 杰克·赫尔水基润滑剂（WL-OJ）；HARU Orgasm 水基润滑剂（WL-OR）；HARU STEAMY 水基润滑剂（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP水基个人润滑剂和保湿剂PINKSLIP, LLCK261909Plum Vagiceuticals® 阴道保湿栓PCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

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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