FDA 510(k)

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K 號：K200502 · 2021-03-31

決定日期2021-03-31

產品代碼KGN

決定相當於

器材摘要

Myriad Particles is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K200502. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Myriad Particles?

Myriad Particles is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K200502.

When did Myriad Particles receive FDA 510(k) clearance?

Myriad Particles received FDA 510(k) clearance on 2021-03-31, under 510(k) number K200502.

Who is the listed applicant for Myriad Particles?

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

What is the FDA product code for Myriad Particles?

The FDA product code for Myriad Particles is KGN.

其他以 Aroa Biosurgery , 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。

K260669Endoform皮膚模板 K250598Endoform 重構模板 - PLGA K231305Endoform 牙科膠膜 K223373Enivo™K200413交響曲 K183398Endoform Restella

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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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