FDA 510(k)

Glo-Tip喷雾导管

K号: K182319 · 2019-02-01

决定日期2019-02-01

产品代码OCX

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决定实质等同

器械摘要

Glo-Tip Spray Catheter 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 2019-02-01 under 510(k) number K182319. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Glo-Tip Spray Catheter?

Glo-Tip Spray Catheter is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K182319.

When did Glo-Tip Spray Catheter receive FDA 510(k) clearance?

Glo-Tip Spray Catheter received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182319.

Who is the listed applicant for Glo-Tip Spray Catheter?

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 Glo-Tip Spray Catheter?

The FDA product code for Glo-Tip Spray Catheter is OCX.

列明Wilson-Cook Medical, 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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