FDA 510(k)

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

K号: K162965 · 2017-02-16

决定日期2017-02-16

产品代码FTM

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决定实质等同

器械摘要

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162965. 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 SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K162965.

When did SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction receive FDA 510(k) clearance?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162965.

Who is the listed applicant for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

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

What is the FDA product code for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

The FDA product code for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is FTM.

列明Tei Biosciences, Inc.为申报人的其他记录

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