LumenR组织拉钩系统
K号: K153698 · 2016-04-19
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申请人Lumenr, LLC
决定日期2016-04-19
产品代码ODB
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
LumenR Tissue Retractor System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenr, LLC. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153698. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LumenR Tissue Retractor System?
LumenR Tissue Retractor System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is Lumenr, LLC. The 510(k) number is K153698.
When did LumenR Tissue Retractor System receive FDA 510(k) clearance?
LumenR Tissue Retractor System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153698.
Who is the listed applicant for LumenR Tissue Retractor System?
The FDA 510(k) record lists Lumenr, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LumenR Tissue Retractor System?
The FDA product code for LumenR Tissue Retractor System is ODB.
相关临床试验
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相关器械（代码：ODB）
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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