FDA 510(k)

结扎设备

K号: K172985 · 2018-06-14

决定日期2018-06-14

产品代码FHN

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决定实质等同

器械摘要

Ligation Device is the device name listed in this FDA 510(k) record. The listed applicant is Leo Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172985. The device is classified under product code FHN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ligation Device?

Ligation Device is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Leo Medical Co., Ltd.. The 510(k) number is K172985.

When did Ligation Device receive FDA 510(k) clearance?

Ligation Device received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172985.

Who is the listed applicant for Ligation Device?

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

What is the FDA product code for Ligation Device?

The FDA product code for Ligation Device is FHN.

列明Leo Medical Co., Ltd.为申报人的其他记录

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