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FDA 510(k)

Cook Intraosseous Infusion Needles

K 號:K160887 · 2016-07-26

決定日期2016-07-26
產品代碼FMI
諮詢委員會HO
決定Substantially Equivalent

器材摘要

Cook Intraosseous Infusion Needles is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160887. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cook Intraosseous Infusion Needles?

Cook Intraosseous Infusion Needles is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Cook Incorporated. The 510(k) number is K160887.

When did Cook Intraosseous Infusion Needles receive FDA 510(k) clearance?

Cook Intraosseous Infusion Needles received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160887.

Who is the listed applicant for Cook Intraosseous Infusion Needles?

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

What is the FDA product code for Cook Intraosseous Infusion Needles?

The FDA product code for Cook Intraosseous Infusion Needles is FMI.

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其他以 Cook Incorporated 為申請人之記錄

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相關器械(代碼:FMI)

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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