Agape 冷却个人润滑剂
K号: K200894 · 2020-07-02
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决定日期2020-07-02
产品代码NUC
咨询委员会OB
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器械摘要
Agape Cooling 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 2020-07-02 under 510(k) number K200894. 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 Agape Cooling Personal Lubricant?
Agape Cooling Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is CC Wellness, LLC. The 510(k) number is K200894.
When did Agape Cooling Personal Lubricant receive FDA 510(k) clearance?
Agape Cooling Personal Lubricant received FDA 510(k) clearance on 2020-07-02, under 510(k) number K200894.
Who is the listed applicant for Agape Cooling 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 Agape Cooling Personal Lubricant?
The FDA product code for Agape Cooling Personal Lubricant 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。
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。
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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