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FDA 510(k)

YES油基個人潤滑劑，YES水基個人潤滑劑，YES陰道潤滑劑

K 號：K162569 · 2017-06-09

申請人Biotech Lubricants, Ltd.
決定日期2017-06-09
產品代碼NUC
諮詢委員會OB設備之醫療設備規範文本翻譯如下： 關於OB設備的醫療設備規範文件： 此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址： 識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NUC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer 水基潤滑劑（WL-OJ）；HARU Orgasm 水基潤滑劑（WL-OR）；HARU STEAMY 水基潤滑劑（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP 水基個人潤滑劑及保濕劑PINKSLIP, LLCK261909Plum Vagiceuticals™ 阴道潤滑栓PCCA, Inc.K254011流動水性個人潤滑劑LBDO Group, Inc.

官方來源

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