FDA 510(k)

Endoform 重建模板

K号: K153633 · 2016-03-15

申请人Aroa Biosurgery Limited (Formerly Mesynthes Limited)

决定日期2016-03-15

产品代码FTM

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决定实质等同

器械摘要

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 2016-03-15 under 510(k) number K153633. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoform Reconstructive Template?

Endoform Reconstructive Template is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Aroa Biosurgery Limited (Formerly Mesynthes Limited). The 510(k) number is K153633.

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

Endoform Reconstructive Template received FDA 510(k) clearance on 2016-03-15, under 510(k) number K153633.

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 FTM.

列明Aroa Biosurgery Limited (Formerly Mesynthes Limited)为申报人的其他记录

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K153632Endoform 重建模板

官方来源

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