FDA 510(k)

SurgiMend MP 软組織重建用膠原膠質

K 號：K162965 · 2017-02-16

決定日期2017-02-16

產品代碼FTM

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

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.

常見問題

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.

其他以 Tei Biosciences, Inc. 為申請人之記錄

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相關器械（代碼：FTM）

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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