FDA 510(k)

特洛伊TM 藍色個人潤滑劑（H2O 敏感觸碰個人潤滑劑）

K 號：K180764 · 2018-08-01

決定日期2018-08-01

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

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K180764. 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 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K180764.

When did TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) receive FDA 510(k) clearance?

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) received FDA 510(k) clearance on 2018-08-01, under 510(k) number K180764.

Who is the listed applicant for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

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

What is the FDA product code for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

The FDA product code for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is NUC.

其他以 Church & Dwight Co., Inc. 為申請人之記錄

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相關器械（代碼：NUC）

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