FDA 510(k)

米羅馬特生物網格

K 號：K160400 · 2016-06-08

決定日期2016-06-08

產品代碼OXH

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 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 2016-06-08 under 510(k) number K160400. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Miromatrix Biological Mesh?

Miromatrix Biological Mesh is a medical device that received FDA 510(k) clearance on 2016-06-08. The listed applicant is Miromatrix Medical, Inc.. The 510(k) number is K160400.

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

Miromatrix Biological Mesh received FDA 510(k) clearance on 2016-06-08, under 510(k) number K160400.

Who is the listed applicant for Miromatrix Biological Mesh?

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?

The FDA product code for Miromatrix Biological Mesh is OXH.

其他以 Miromatrix Medical, Inc. 為申請人之記錄

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K162570米羅馬特生物網格 TW

相關器械（代碼：OXH）

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K251844Kerecis SurgiBind (50241)Kerecis Limited K202430Kerecis 重構Kerecis Limited K171357SurgiMend PRS 網狀，Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)

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