FDA 510(k)

ABCcolla 膠原蛋白組織

K 號：K162348 · 2017-05-10

決定日期2017-05-10

產品代碼KGN

決定相當於

器材摘要

ABCcolla Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-10 under 510(k) number K162348. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the ABCcolla Collagen Matrix?

ABCcolla Collagen Matrix is a medical device that received FDA 510(k) clearance on 2017-05-10. The listed applicant is Acro Biomedical Co., Ltd.. The 510(k) number is K162348.

When did ABCcolla Collagen Matrix receive FDA 510(k) clearance?

ABCcolla Collagen Matrix received FDA 510(k) clearance on 2017-05-10, under 510(k) number K162348.

Who is the listed applicant for ABCcolla Collagen Matrix?

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

What is the FDA product code for ABCcolla Collagen Matrix?

The FDA product code for ABCcolla Collagen Matrix is KGN.

其他以 Acro Biomedical 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。

K233378ABCcolla® 膠原蛋白 ADM 支架 K212156ABCcolla 骨組織 K171629ABCcolla 骨移植材料

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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