FDA 510(k)

Precifit Medical Kirschner Wires

K号: K163327 · 2017-05-08

决定日期2017-05-08

产品代码HTY

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

Precifit Medical Kirschner Wires is the device name listed in this FDA 510(k) record. The listed applicant is Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K163327. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Precifit Medical Kirschner Wires?

Precifit Medical Kirschner Wires is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Precifit Medical, Ltd.. The 510(k) number is K163327.

When did Precifit Medical Kirschner Wires receive FDA 510(k) clearance?

Precifit Medical Kirschner Wires received FDA 510(k) clearance on 2017-05-08, under 510(k) number K163327.

Who is the listed applicant for Precifit Medical Kirschner Wires?

The FDA 510(k) record lists Precifit Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precifit Medical Kirschner Wires?

The FDA product code for Precifit Medical Kirschner Wires is HTY.

列明Precifit Medical, Ltd.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。

K173189Lumfuse TP K172568Cervage K171630LumFuse-TP

官方来源

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