FDA 510(k)

Golnit 尼龙单丝缝合线

K号: K212888 · 2022-03-31

决定日期2022-03-31

产品代码GAR

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决定实质等同

器械摘要

Golnit Nylon Monofilament Suture is the device name listed in this FDA 510(k) record. The listed applicant is Antarma, LLC Dba Golnit Sutures. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K212888. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Golnit Nylon Monofilament Suture?

Golnit Nylon Monofilament Suture is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Antarma, LLC Dba Golnit Sutures. The 510(k) number is K212888.

When did Golnit Nylon Monofilament Suture receive FDA 510(k) clearance?

Golnit Nylon Monofilament Suture received FDA 510(k) clearance on 2022-03-31, under 510(k) number K212888.

Who is the listed applicant for Golnit Nylon Monofilament Suture?

The FDA 510(k) record lists Antarma, LLC Dba Golnit Sutures as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Golnit Nylon Monofilament Suture?

The FDA product code for Golnit Nylon Monofilament Suture is GAR.

列明Antarma, LLC Dba Golnit Sutures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。

K192088GOLNIT 不可吸收 PTFE 外科缝合线

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