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FDA 510(k)

吸引灌洗組合

K 號：K172794 · 2017-11-29

申請人Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
決定日期2017-11-29
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Suction Irrigation Set is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172794. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Suction Irrigation Set?

Suction Irrigation Set is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K172794.

When did Suction Irrigation Set receive FDA 510(k) clearance?

Suction Irrigation Set received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172794.

Who is the listed applicant for Suction Irrigation Set?

The FDA 510(k) record lists Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suction Irrigation Set?

The FDA product code for Suction Irrigation Set is GCJ.

相關臨床試驗

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其他以 Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd 為申請人之記錄

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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相關器械（代碼：GCJ）

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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