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FDA 510(k)

杜拉美仕網狀縫線

K 號:K211178 · 2022-09-02

申請人Msi
決定日期2022-09-02
產品代碼GAW
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

DURAMESH Mesh Suture is the device name listed in this FDA 510(k) record. The listed applicant is Msi. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K211178. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DURAMESH Mesh Suture?

DURAMESH Mesh Suture is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Msi. The 510(k) number is K211178.

When did DURAMESH Mesh Suture receive FDA 510(k) clearance?

DURAMESH Mesh Suture received FDA 510(k) clearance on 2022-09-02, under 510(k) number K211178.

Who is the listed applicant for DURAMESH Mesh Suture?

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

What is the FDA product code for DURAMESH Mesh Suture?

The FDA product code for DURAMESH Mesh Suture is GAW.

相關臨床試驗

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相關器械(代碼:GAW)

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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