FDA 510(k)

特洛伊超潤滑聚氨酯男性避孕套

K 號：K171639 · 2017-08-01

決定日期2017-08-01

產品代碼MOL

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 Supra Lubricated Polyurethane Male Condom 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 2017-08-01 under 510(k) number K171639. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trojan Supra Lubricated Polyurethane Male Condom?

Trojan Supra Lubricated Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K171639.

When did Trojan Supra Lubricated Polyurethane Male Condom receive FDA 510(k) clearance?

Trojan Supra Lubricated Polyurethane Male Condom received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171639.

Who is the listed applicant for Trojan Supra Lubricated Polyurethane Male Condom?

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 Supra Lubricated Polyurethane Male Condom?

The FDA product code for Trojan Supra Lubricated Polyurethane Male Condom is MOL.

其他以 Church & Dwight Co., 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。

K243640特洛揚™超細肋線快樂膠乳避孕套（潤滑型）（特洛揚™超細肋線快樂膠乳避孕套）K240379特洛揚 SIS 合成橡膠避孕套，配備矽膠潤滑劑 K221906特洛揚火與冰潤滑男性天然橡膠乳膠避孕套 K221431TROJAN™ 她的快樂加熱男性天然橡膠乳膠避孕套，搭配加熱潤滑劑 K203818Replens 長效陰道潤膚劑 K193450Pre-Seed™ 孕育潤滑劑

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相關器械（代碼：MOL）

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。

K252158Sagami 原創 002 聚氨酯男性避孕套Mayer Laboratories K243967一個尼龍乳膠避孕套Global Protection Corp.K241617杜蕾斯多異丙烯膠避孕套Rb Health (Us), LLC K240379特洛揚 SIS 合成橡膠避孕套，配備矽膠潤滑劑Church & Dwight Co., Inc.K240896一個尼龍乳膠避孕套Global Protection Corp.K232470多異戊二烯超大號避孕套Suretex Limited

官方來源

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