FDA 510(k)

無香W長塑膠及紙質應用器衛生棉棒

K 號：K191666 · 2019-12-20

決定日期2019-12-20

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

Unscented W long plastic and cardboard applicator tampons is the device name listed in this FDA 510(k) record. The listed applicant is Ontex Bvba. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191666. 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 Unscented W long plastic and cardboard applicator tampons?

Unscented W long plastic and cardboard applicator tampons is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Ontex Bvba. The 510(k) number is K191666.

When did Unscented W long plastic and cardboard applicator tampons receive FDA 510(k) clearance?

Unscented W long plastic and cardboard applicator tampons received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191666.

Who is the listed applicant for Unscented W long plastic and cardboard applicator tampons?

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

What is the FDA product code for Unscented W long plastic and cardboard applicator tampons?

The FDA product code for Unscented W long plastic and cardboard applicator tampons is HEB.

其他以 Ontex Bvba 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。

K162746Ontex以及其他專有名稱

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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