FDA 510(k)

45 微米聚異丁烯避孕套

K 號：K231908 · 2023-10-27

決定日期2023-10-27

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

45 Micron Polyisoprene Condom is the device name listed in this FDA 510(k) record. The listed applicant is Suretex Limited. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231908. 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 45 Micron Polyisoprene Condom?

45 Micron Polyisoprene Condom is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Suretex Limited. The 510(k) number is K231908.

When did 45 Micron Polyisoprene Condom receive FDA 510(k) clearance?

45 Micron Polyisoprene Condom received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231908.

Who is the listed applicant for 45 Micron Polyisoprene Condom?

The FDA 510(k) record lists Suretex Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 45 Micron Polyisoprene Condom?

The FDA product code for 45 Micron Polyisoprene Condom is MOL.

其他以 Suretex Limited 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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官方來源

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