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FDA 510(k)

Assut Filbloc 永久縫線

K 號:K171039 · 2017-08-29

決定日期2017-08-29
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

Assut Filbloc Permanent Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Assut Europe S.P.A.. It received FDA 510(k) clearance on 2017-08-29 under 510(k) number K171039. 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 Assut Filbloc Permanent Sutures?

Assut Filbloc Permanent Sutures is a medical device that received FDA 510(k) clearance on 2017-08-29. The listed applicant is Assut Europe S.P.A.. The 510(k) number is K171039.

When did Assut Filbloc Permanent Sutures receive FDA 510(k) clearance?

Assut Filbloc Permanent Sutures received FDA 510(k) clearance on 2017-08-29, under 510(k) number K171039.

Who is the listed applicant for Assut Filbloc Permanent Sutures?

The FDA 510(k) record lists Assut Europe S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Assut Filbloc Permanent Sutures?

The FDA product code for Assut Filbloc Permanent Sutures 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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