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FDA 510(k)

多碘烷酮外科支架

K 號：K181094 · 2018-08-02

申請人Lntegra Lifesciences
決定日期2018-08-02
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

Polydioxanone Surgical Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Lntegra Lifesciences. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181094. 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 Polydioxanone Surgical Scaffold?

Polydioxanone Surgical Scaffold is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Lntegra Lifesciences. The 510(k) number is K181094.

When did Polydioxanone Surgical Scaffold receive FDA 510(k) clearance?

Polydioxanone Surgical Scaffold received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181094.

Who is the listed applicant for Polydioxanone Surgical Scaffold?

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

What is the FDA product code for Polydioxanone Surgical Scaffold?

The FDA product code for Polydioxanone Surgical Scaffold is FTL.

相關臨床試驗

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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。

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官方來源

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