FDA 510(k)

高級溫暖個人潤滑劑，高級肛門溫暖潤滑劑，全效溫暖

K 號：K200457 · 2020-05-22

決定日期2020-05-22

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

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming 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 2020-05-22 under 510(k) number K200457. 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 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is CC Wellness, LLC. The 510(k) number is K200457.

When did Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming receive FDA 510(k) clearance?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming received FDA 510(k) clearance on 2020-05-22, under 510(k) number K200457.

Who is the listed applicant for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

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 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

The FDA product code for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is NUC.

其他以 CC Wellness, LLC 為申請人之記錄

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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。

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官方來源

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