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FDA 510(k)

Holycon 合成可吸收缝合线

K号: K173043 · 2017-12-14

决定日期2017-12-14
产品代码GAM
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决定实质等同

器械摘要

Holycon Synthetic Absorbable Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Nantong Holycon Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K173043. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Holycon Synthetic Absorbable Sutures?

Holycon Synthetic Absorbable Sutures is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Nantong Holycon Medical Devices Co., Ltd.. The 510(k) number is K173043.

When did Holycon Synthetic Absorbable Sutures receive FDA 510(k) clearance?

Holycon Synthetic Absorbable Sutures received FDA 510(k) clearance on 2017-12-14, under 510(k) number K173043.

Who is the listed applicant for Holycon Synthetic Absorbable Sutures?

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

What is the FDA product code for Holycon Synthetic Absorbable Sutures?

The FDA product code for Holycon Synthetic Absorbable Sutures is GAM.

相关临床试验

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相关器械(代码:GAM)

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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