FDA 510(k)

特洛伊XOXO超薄男性天然乳胶避孕套，含硅酮和芦荟潤滑劑

K 號：K161545 · 2016-08-26

決定日期2016-08-26

產品代碼HIS

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

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe 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 2016-08-26 under 510(k) number K161545. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K161545.

When did Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant receive FDA 510(k) clearance?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161545.

Who is the listed applicant for Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe 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 Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

The FDA product code for Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is HIS.

其他以 Church & Dwight Co., Inc. 為申請人之記錄

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相關器械（代碼：HIS）

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。

官方來源

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