FDA 510(k)

COLORADO THERAPEUTICS异种移植植入物

K号: K160181 · 2016-10-20

决定日期2016-10-20

产品代码FTM

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决定实质等同

器械摘要

COLORADO THERAPEUTICS XENOGRAFT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Colorado Therapeutics, LLC. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K160181. 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 COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

COLORADO THERAPEUTICS XENOGRAFT IMPLANT is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Colorado Therapeutics, LLC. The 510(k) number is K160181.

When did COLORADO THERAPEUTICS XENOGRAFT IMPLANT receive FDA 510(k) clearance?

COLORADO THERAPEUTICS XENOGRAFT IMPLANT received FDA 510(k) clearance on 2016-10-20, under 510(k) number K160181.

Who is the listed applicant for COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

The FDA 510(k) record lists Colorado Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLORADO THERAPEUTICS XENOGRAFT IMPLANT?

The FDA product code for COLORADO THERAPEUTICS XENOGRAFT IMPLANT is FTM.

列明Colorado Therapeutics, LLC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。

K172937Colorado Therapeutics Xenograft Implant

官方来源

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