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FDA 510(k)

YES油基个人润滑剂，YES水基个人润滑剂，YES阴道保湿剂

K号: K162569 · 2017-06-09

申请人Biotech Lubricants, Ltd.
决定日期2017-06-09
产品代码NUC
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决定实质等同

器械摘要

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Lubricants, Ltd.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K162569. 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 YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer?

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Biotech Lubricants, Ltd.. The 510(k) number is K162569.

When did YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer receive FDA 510(k) clearance?

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer received FDA 510(k) clearance on 2017-06-09, under 510(k) number K162569.

Who is the listed applicant for YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer?

The FDA 510(k) record lists Biotech Lubricants, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer?

The FDA product code for YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer 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

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

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