pjur 女士裸色 pjur med 敏感顺滑
K号: K200730 · 2020-12-17
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决定日期2020-12-17
产品代码NUC
咨询委员会OB
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决定实质等同
器械摘要
pjur WOMAN Nude pjur med SENSITIVE glide is the device name listed in this FDA 510(k) record. The listed applicant is Pjur Group Luxembourg S.A.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K200730. 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 pjur WOMAN Nude pjur med SENSITIVE glide?
pjur WOMAN Nude pjur med SENSITIVE glide is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Pjur Group Luxembourg S.A.. The 510(k) number is K200730.
When did pjur WOMAN Nude pjur med SENSITIVE glide receive FDA 510(k) clearance?
pjur WOMAN Nude pjur med SENSITIVE glide received FDA 510(k) clearance on 2020-12-17, under 510(k) number K200730.
Who is the listed applicant for pjur WOMAN Nude pjur med SENSITIVE glide?
The FDA 510(k) record lists Pjur Group Luxembourg S.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for pjur WOMAN Nude pjur med SENSITIVE glide?
The FDA product code for pjur WOMAN Nude pjur med SENSITIVE glide 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Pjur Group Luxembourg S.A.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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