FDA 510(k)

Skyn 原味聚异戊二烯潤滑男性避孕套 - 味道型

K 號：K171172 · 2017-08-02

決定日期2017-08-02

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

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-08-02 under 510(k) number K171172. 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 Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is a medical device that received FDA 510(k) clearance on 2017-08-02. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171172.

When did Skyn Original Polyisoprene Lubricated Male Condom - Flavored receive FDA 510(k) clearance?

Skyn Original Polyisoprene Lubricated Male Condom - Flavored received FDA 510(k) clearance on 2017-08-02, under 510(k) number K171172.

Who is the listed applicant for Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

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

What is the FDA product code for Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

The FDA product code for Skyn Original Polyisoprene Lubricated Male Condom - Flavored is MOL.

其他以 Ansell Healthcare Products, 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。

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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。

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