FDA 510(k)

Restrata 瘘傷組織

K 號：K170300 · 2017-04-26

決定日期2017-04-26

產品代碼QSZ

決定相當於

器材摘要

Restrata Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170300. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常見問題

What is the Restrata Wound Matrix?

Restrata Wound Matrix is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K170300.

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

Restrata Wound Matrix received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170300.

Who is the listed applicant for Restrata Wound Matrix?

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

What is the FDA product code for Restrata Wound Matrix?

The FDA product code for Restrata Wound Matrix is QSZ.

其他以 Acera Surgical, Inc. 為申請人之記錄

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相關器械（代碼：QSZ）

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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