FDA 510(k)

丹尼克钛質結合夾

K 號：K192711 · 2019-12-20

申請人Dannik

決定日期2019-12-20

產品代碼FZP

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

Dannik Titanium Ligation Clip is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192711. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dannik Titanium Ligation Clip?

Dannik Titanium Ligation Clip is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Dannik. The 510(k) number is K192711.

When did Dannik Titanium Ligation Clip receive FDA 510(k) clearance?

Dannik Titanium Ligation Clip received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192711.

Who is the listed applicant for Dannik Titanium Ligation Clip?

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

What is the FDA product code for Dannik Titanium Ligation Clip?

The FDA product code for Dannik Titanium Ligation Clip is FZP.

其他以 Dannik 為申請人之記錄

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相關器械（代碼：FZP）

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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