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FDA 510(k)

SUERCELL 凝膠纖維傷口敷料

K 號:K173005 · 2018-05-25

決定日期2018-05-25
產品代碼KGN
決定相當於

器材摘要

SURECELL Gelling Fiber Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Newvalue Medical Producst Co.,Ltd. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K173005. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the SURECELL Gelling Fiber Wound Dressing?

SURECELL Gelling Fiber Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Jiangsu Newvalue Medical Producst Co.,Ltd. The 510(k) number is K173005.

When did SURECELL Gelling Fiber Wound Dressing receive FDA 510(k) clearance?

SURECELL Gelling Fiber Wound Dressing received FDA 510(k) clearance on 2018-05-25, under 510(k) number K173005.

Who is the listed applicant for SURECELL Gelling Fiber Wound Dressing?

The FDA 510(k) record lists Jiangsu Newvalue Medical Producst Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURECELL Gelling Fiber Wound Dressing?

The FDA product code for SURECELL Gelling Fiber Wound Dressing is KGN.

相關臨床試驗

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相關器械(代碼:KGN)

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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