FDA 510(k)

Actively Trying Personal Lubricant Rose Scented

K 號：K212885 · 2022-02-11

決定日期2022-02-11

產品代碼PEB

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

Actively Trying Personal Lubricant Rose Scented is the device name listed in this FDA 510(k) record. The listed applicant is CC Wellness, LLC. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K212885. The device is classified under product code PEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Actively Trying Personal Lubricant Rose Scented?

Actively Trying Personal Lubricant Rose Scented is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is CC Wellness, LLC. The 510(k) number is K212885.

When did Actively Trying Personal Lubricant Rose Scented receive FDA 510(k) clearance?

Actively Trying Personal Lubricant Rose Scented received FDA 510(k) clearance on 2022-02-11, under 510(k) number K212885.

Who is the listed applicant for Actively Trying Personal Lubricant Rose Scented?

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

What is the FDA product code for Actively Trying Personal Lubricant Rose Scented?

The FDA product code for Actively Trying Personal Lubricant Rose Scented is PEB.

其他以 CC Wellness, LLC 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。

K232091椰子混合冷效個人潤滑劑 K232090J.O. 椰子混合保暖個人潤滑劑 K230674JO 水基分析濃滑潤滑劑 2oz 型號 40112, JO 水基分析濃滑潤滑劑 4oz 型號 40112, JO 水基分析濃滑潤滑劑 8oz 型號 40114 K221908JO CUMPLAY 個人潤滑劑 K212705Actively Trying Personal Lubricant Unfragrance K210986H2O冷卻個人潤滑劑，H2O分析冷卻個人潤滑劑，#LubeLife Sensations冷卻，#LubeLife Sensations雙人快樂套裝，JO 2 To Tango for Me，JO 2 To Tango夫妻快樂套裝

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相關器械（代碼：PEB）

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。

K212705Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC K193450Pre-Seed™ 孕育潤滑劑Church & Dwight Co., Inc.K190872生物基因生育潤滑劑Good Clean Love, Inc.K182585JO積極試用個人潤滑劑United Consortium K162319BabyDance 生育潤滑劑Fairhaven Health, LLC

官方來源

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