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FDA 510(k)

ROP可吸收止血材料

K号: K153095 · 2016-02-17

决定日期2016-02-17
产品代码MTJ
决定实质等同

器械摘要

ROP Resorbable Hemostasis Material is the device name listed in this FDA 510(k) record. The listed applicant is Resorbable Orthopedic Products, LLC. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K153095. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

常见问题

What is the ROP Resorbable Hemostasis Material?

ROP Resorbable Hemostasis Material is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Resorbable Orthopedic Products, LLC. The 510(k) number is K153095.

When did ROP Resorbable Hemostasis Material receive FDA 510(k) clearance?

ROP Resorbable Hemostasis Material received FDA 510(k) clearance on 2016-02-17, under 510(k) number K153095.

Who is the listed applicant for ROP Resorbable Hemostasis Material?

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

What is the FDA product code for ROP Resorbable Hemostasis Material?

The FDA product code for ROP Resorbable Hemostasis Material is MTJ.

相关临床试验

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相关器械(代码:MTJ)

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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