FDA 510(k)

ARTIA 重建组织基质穿孔

K号: K162752 · 2017-02-24

决定日期2017-02-24

产品代码FTM

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决定实质等同

器械摘要

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.

常见问题

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.

列明Lifecell Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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