KY Banksy湿度
K号: K183505 · 2019-05-17
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决定日期2019-05-17
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
KY Banksy Moisture is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K183505. 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 KY Banksy Moisture?
KY Banksy Moisture is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K183505.
When did KY Banksy Moisture receive FDA 510(k) clearance?
KY Banksy Moisture received FDA 510(k) clearance on 2019-05-17, under 510(k) number K183505.
Who is the listed applicant for KY Banksy Moisture?
The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KY Banksy Moisture?
The FDA product code for KY Banksy Moisture 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Rb Health (Us), 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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