FDA 510(k)

LUVENA 阴道潤膚乳液及潤滑劑

K 號：K162235 · 2017-03-24

決定日期2017-03-24

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

LUVENA VAGINAL MOISTURIZER & LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Laclede, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162235. 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 LUVENA VAGINAL MOISTURIZER & LUBRICANT?

LUVENA VAGINAL MOISTURIZER & LUBRICANT is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Laclede, Inc.. The 510(k) number is K162235.

When did LUVENA VAGINAL MOISTURIZER & LUBRICANT receive FDA 510(k) clearance?

LUVENA VAGINAL MOISTURIZER & LUBRICANT received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162235.

Who is the listed applicant for LUVENA VAGINAL MOISTURIZER & LUBRICANT?

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

What is the FDA product code for LUVENA VAGINAL MOISTURIZER & LUBRICANT?

The FDA product code for LUVENA VAGINAL MOISTURIZER & LUBRICANT is NUC.

其他以 Laclede, Inc. 為申請人之記錄

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。

K240508Salivea乾口異常保濕膠（乾口異常保濕膠）K180680Salivea乾口腔漱口水，Salivea乾口腔噴劑

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, LLC K253989HARU 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, LLC K261909Plum 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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。