FDA 510(k)

Medline ReNewal Reprocessed Carter-Thomason 针尖缝合线通过器

K号: K182828 · 2019-04-15

申请人Surgical Instrument Service and Savings, Inc.

决定日期2019-04-15

产品代码NLM

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K182828. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K182828.

When did Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer received FDA 510(k) clearance on 2019-04-15, under 510(k) number K182828.

Who is the listed applicant for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

The FDA product code for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is NLM.

列明Surgical Instrument Service and Savings, Inc.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。

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