FDA 510(k)

米羅馬特生物網格 TW

K 號：K162570 · 2017-02-16

決定日期2017-02-16

產品代碼FTM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Miromatrix Biological Mesh TW is the device name listed in this FDA 510(k) record. The listed applicant is Miromatrix Medical, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162570. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Miromatrix Biological Mesh TW?

Miromatrix Biological Mesh TW is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Miromatrix Medical, Inc.. The 510(k) number is K162570.

When did Miromatrix Biological Mesh TW receive FDA 510(k) clearance?

Miromatrix Biological Mesh TW received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162570.

Who is the listed applicant for Miromatrix Biological Mesh TW?

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

What is the FDA product code for Miromatrix Biological Mesh TW?

The FDA product code for Miromatrix Biological Mesh TW is FTM.

其他以 Miromatrix Medical, Inc. 為申請人之記錄

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K160400米羅馬特生物網格

相關器械（代碼：FTM）

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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