FDA 510(k)

NeoMatriX 瘘管組織

K 號：K181330 · 2018-10-11

決定日期2018-10-11

產品代碼KGN

決定相當於

器材摘要

NeoMatriX Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Nextgen Biologics, Inc.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K181330. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the NeoMatriX Wound Matrix?

NeoMatriX Wound Matrix is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Nextgen Biologics, Inc.. The 510(k) number is K181330.

When did NeoMatriX Wound Matrix receive FDA 510(k) clearance?

NeoMatriX Wound Matrix received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181330.

Who is the listed applicant for NeoMatriX Wound Matrix?

The FDA 510(k) record lists Nextgen Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeoMatriX Wound Matrix?

The FDA product code for NeoMatriX Wound Matrix is KGN.

其他以 Nextgen Biologics, Inc. 為申請人之記錄

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K210024NeoMatriX 瘘管組織

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。

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官方來源

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