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FDA 510(k)

Signia sterilization tray

K 號:K161347 · 2016-09-07

申請人Covidien
決定日期2016-09-07
產品代碼KCT
諮詢委員會HO
決定Substantially Equivalent

器材摘要

Signia sterilization tray is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K161347. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Signia sterilization tray?

Signia sterilization tray is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Covidien. The 510(k) number is K161347.

When did Signia sterilization tray receive FDA 510(k) clearance?

Signia sterilization tray received FDA 510(k) clearance on 2016-09-07, under 510(k) number K161347.

Who is the listed applicant for Signia sterilization tray?

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

What is the FDA product code for Signia sterilization tray?

The FDA product code for Signia sterilization tray is KCT.

相關臨床試驗

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其他以 Covidien 為申請人之記錄

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相關器械(代碼:KCT)

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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