FDA 510(k)

ARTIA 重構組織膠質網孔板

K 號：K162752 · 2017-02-24

決定日期2017-02-24

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

ARTIA Reconstructive Tissue Matrix Perforated is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corporation. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162752. 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 ARTIA Reconstructive Tissue Matrix Perforated?

ARTIA Reconstructive Tissue Matrix Perforated is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Lifecell Corporation. The 510(k) number is K162752.

When did ARTIA Reconstructive Tissue Matrix Perforated receive FDA 510(k) clearance?

ARTIA Reconstructive Tissue Matrix Perforated received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162752.

Who is the listed applicant for ARTIA Reconstructive Tissue Matrix Perforated?

The FDA 510(k) record lists Lifecell Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTIA Reconstructive Tissue Matrix Perforated?

The FDA product code for ARTIA Reconstructive Tissue Matrix Perforated is FTM.

其他以 Lifecell Corporation 為申請人之記錄

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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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官方來源

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