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FDA 510(k)

AcuSnare息肉摘除圈 - 鸭嘴型

K号: K191048 · 2019-07-18

决定日期2019-07-18
产品代码FDI
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

AcuSnare Polypectomy Snare - Duckbill is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K191048. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AcuSnare Polypectomy Snare - Duckbill?

AcuSnare Polypectomy Snare - Duckbill is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K191048.

When did AcuSnare Polypectomy Snare - Duckbill receive FDA 510(k) clearance?

AcuSnare Polypectomy Snare - Duckbill received FDA 510(k) clearance on 2019-07-18, under 510(k) number K191048.

Who is the listed applicant for AcuSnare Polypectomy Snare - Duckbill?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AcuSnare Polypectomy Snare - Duckbill?

The FDA product code for AcuSnare Polypectomy Snare - Duckbill is FDI.

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列明Wilson-Cook Medical, Inc.为申报人的其他记录

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相关器械(代码:FDI)

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。

官方来源

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