FDA 510(k)

杜阿泰恩雙層網格

K 號：K172395 · 2018-02-01

決定日期2018-02-01

產品代碼FTL

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Duatene bilayer mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K172395. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Duatene bilayer mesh?

Duatene bilayer mesh is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Sofradim Production. The 510(k) number is K172395.

When did Duatene bilayer mesh receive FDA 510(k) clearance?

Duatene bilayer mesh received FDA 510(k) clearance on 2018-02-01, under 510(k) number K172395.

Who is the listed applicant for Duatene bilayer mesh?

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

What is the FDA product code for Duatene bilayer mesh?

The FDA product code for Duatene bilayer mesh is FTL.

其他以 Sofradim Production 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。

K253956ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene™ 大孔網膜 (PPM5050)K243315ProGrip™ 自粘性聚丙烯網 K233661Transorb™ 自粘性可吸收網格 K232373Progrip™ 自攝式聚丙烯網格 K223218帕瑞特尼大孔網

查看所有 11 項裝置 →

相關器械（代碼：FTL）

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。

K253956ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production K253125Parietene™ 平面網狀布Medtronic - Sofradim Production K251955Onflex™ 網狀物Davol Inc., Subsidiary of C. R. Bard, Inc.K251557巴德® 網膜；巴德® 預成型網膜Davol, Inc.K250869Parietene™ 大孔網膜 (PPM5050)Sofradim Production K250098巴德柔 mesh；巴德柔柔 mesh 預成型Davol, Inc.

官方來源

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