FDA 510(k)

NovoGen 瘘口網絡

K 號：K220498 · 2023-06-09

決定日期2023-06-09

產品代碼KGN

決定相當於

器材摘要

NovoGen Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K220498. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the NovoGen Wound Matrix?

NovoGen Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Novabone Products, LLC. The 510(k) number is K220498.

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

NovoGen Wound Matrix received FDA 510(k) clearance on 2023-06-09, under 510(k) number K220498.

Who is the listed applicant for NovoGen Wound Matrix?

The FDA 510(k) record lists Novabone Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoGen Wound Matrix?

The FDA product code for NovoGen Wound Matrix is KGN.

其他以 Novabone Products, LLC 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。

K242299NovaBone Putty - 合成生物活性骨移植材 K240404NovaBone Putty - 生物活性合成骨移植材 (NB6600, NB6610, NB6615)K163310諾瓦骨IRM

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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