FDA 510(k)

間奏式塑膠應用器包裝衛生棉條

K 號：K191431 · 2019-10-07

決定日期2019-10-07

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

Interlude Rolled Tampons in Plastic Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Albaad Fem. It received FDA 510(k) clearance on 2019-10-07 under 510(k) number K191431. 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 Interlude Rolled Tampons in Plastic Applicator?

Interlude Rolled Tampons in Plastic Applicator is a medical device that received FDA 510(k) clearance on 2019-10-07. The listed applicant is Albaad Fem. The 510(k) number is K191431.

When did Interlude Rolled Tampons in Plastic Applicator receive FDA 510(k) clearance?

Interlude Rolled Tampons in Plastic Applicator received FDA 510(k) clearance on 2019-10-07, under 510(k) number K191431.

Who is the listed applicant for Interlude Rolled Tampons in Plastic Applicator?

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

What is the FDA product code for Interlude Rolled Tampons in Plastic Applicator?

The FDA product code for Interlude Rolled Tampons in Plastic Applicator is HEB.

其他以 Albaad Fem 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。

K181911間奏 100%棉質衛生棉條 K173225間奏曲及私人標籤無香3件式迷你棒狀衛生棉條

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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