FDA 510(k)

有機棉衛生棉棒；有機棉PESCV綸衛生棉棒

K 號：K240708 · 2024-05-10

申請人Suzhou Borage Medical Technology Co., Ltd.

決定日期2024-05-10

產品代碼HEB

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

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Borage Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240708. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Organic Cotton Tampon; Organic Cotton PESCVcord Tampon?

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Suzhou Borage Medical Technology Co., Ltd.. The 510(k) number is K240708.

When did Organic Cotton Tampon; Organic Cotton PESCVcord Tampon receive FDA 510(k) clearance?

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240708.

Who is the listed applicant for Organic Cotton Tampon; Organic Cotton PESCVcord Tampon?

The FDA 510(k) record lists Suzhou Borage Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Organic Cotton Tampon; Organic Cotton PESCVcord Tampon?

The FDA product code for Organic Cotton Tampon; Organic Cotton PESCVcord Tampon is HEB.

其他以 Suzhou Borage Medical Technology Co., Ltd. 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。

K222046無香月經棉塞

相關器械（代碼：HEB）

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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