Urethrotech UCD
K号: K190060 · 2019-10-04
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申请人Urethrotech
决定日期2019-10-04
产品代码EZL
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
Urethrotech UCD is the device name listed in this FDA 510(k) record. The listed applicant is Urethrotech. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190060. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Urethrotech UCD?
Urethrotech UCD is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Urethrotech. The 510(k) number is K190060.
When did Urethrotech UCD receive FDA 510(k) clearance?
Urethrotech UCD received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190060.
Who is the listed applicant for Urethrotech UCD?
The FDA 510(k) record lists Urethrotech as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Urethrotech UCD?
The FDA product code for Urethrotech UCD is EZL.
相关临床试验
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相关器械(代码:EZL)
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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官方来源
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