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FDA 510(k)

Hoffman LRF System

K号: K161753 · 2016-11-15

申请人Stryker GmbH
决定日期2016-11-15
产品代码KTT
咨询委员会OR
决定Substantially Equivalent

器械摘要

Hoffman LRF System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K161753. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hoffman LRF System?

Hoffman LRF System is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Stryker GmbH. The 510(k) number is K161753.

When did Hoffman LRF System receive FDA 510(k) clearance?

Hoffman LRF System received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161753.

Who is the listed applicant for Hoffman LRF System?

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

What is the FDA product code for Hoffman LRF System?

The FDA product code for Hoffman LRF System is KTT.

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列明Stryker GmbH为申报人的其他记录

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相关器械(代码:KTT)

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。

官方来源

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