FDA 510(k)

膠原蛋白傷口敷料

K 號：K231152 · 2023-10-12

決定日期2023-10-12

產品代碼KGN

決定相當於

器材摘要

Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K231152. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Collagen Wound Dressing?

Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K231152.

When did Collagen Wound Dressing receive FDA 510(k) clearance?

Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231152.

Who is the listed applicant for Collagen Wound Dressing?

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

What is the FDA product code for Collagen Wound Dressing?

The FDA product code for Collagen Wound Dressing is KGN.

其他以 Winner Medical 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。

K252001膠原蛋白傷口敷料 K250082程序口罩/外科口罩/臉部口罩 K231057抗菌膠膠布傷口敷料 K231564皮膚與傷口清潔劑 K221311抗菌繃帶 K223232程序口罩/外科口罩/臉部口罩

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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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596膠原蛋白傷口粉末Ventris Medical K260669Endoform皮膚模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。