Astroglide X 硅胶个人润滑剂
K号: K210242 · 2021-04-28
广告
决定日期2021-04-28
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
Astroglide X Silicone Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K210242. 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 Astroglide X Silicone Personal Lubricant?
Astroglide X Silicone Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Biofilm, Inc.. The 510(k) number is K210242.
When did Astroglide X Silicone Personal Lubricant receive FDA 510(k) clearance?
Astroglide X Silicone Personal Lubricant received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210242.
Who is the listed applicant for Astroglide X Silicone Personal Lubricant?
The FDA 510(k) record lists Biofilm, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Astroglide X Silicone Personal Lubricant?
The FDA product code for Astroglide X Silicone 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Biofilm, Inc.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。
广告