FDA 510(k)

LifeStyles NRL 粗糙避孕套

K 號：K232279 · 2023-10-05

決定日期2023-10-05

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

LifeStyles NRL Textured 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 2023-10-05 under 510(k) number K232279. 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 LifeStyles NRL Textured Condom?

LifeStyles NRL Textured Condom is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Suretex Limited. The 510(k) number is K232279.

When did LifeStyles NRL Textured Condom receive FDA 510(k) clearance?

LifeStyles NRL Textured Condom received FDA 510(k) clearance on 2023-10-05, under 510(k) number K232279.

Who is the listed applicant for LifeStyles NRL Textured 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 LifeStyles NRL Textured Condom?

The FDA product code for LifeStyles NRL Textured Condom is HIS.

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。

K252521LifeStyles® HydraFeel 天然乳膠避孕套 K232470多異戊二烯超大號避孕套 K23190845 微米聚異丁烯避孕套 K221243OFNat 滑潤劑（L15）K213921超薄天然乳胶避孕套

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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