FDA 510(k)

Endoform 重構模板

K 號：K153632 · 2016-06-16

申請人Aroa Biosurgery Limited (Formerly Mesynthes Limited)

決定日期2016-06-16

產品代碼FTL

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

Endoform Reconstructive Template is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery Limited (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K153632. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoform Reconstructive Template?

Endoform Reconstructive Template is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Aroa Biosurgery Limited (Formerly Mesynthes Limited). The 510(k) number is K153632.

When did Endoform Reconstructive Template receive FDA 510(k) clearance?

Endoform Reconstructive Template received FDA 510(k) clearance on 2016-06-16, under 510(k) number K153632.

Who is the listed applicant for Endoform Reconstructive Template?

The FDA 510(k) record lists Aroa Biosurgery Limited (Formerly Mesynthes Limited) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoform Reconstructive Template?

The FDA product code for Endoform Reconstructive Template is FTL.

其他以 Aroa Biosurgery Limited (Formerly Mesynthes Limited) 為申請人之記錄

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K153633Endoform 重構模板

相關器械（代碼：FTL）

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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