HANAROSTENT Benefit Biliary (NNN)
K号: K202973 · 2021-05-11
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决定日期2021-05-11
产品代码FGE
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Unknown
器械摘要
HANAROSTENT Benefit Biliary (NNN) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-05-11 under 510(k) number K202973. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.
常见问题
What is the HANAROSTENT Benefit Biliary (NNN)?
HANAROSTENT Benefit Biliary (NNN) is a medical device that received FDA 510(k) clearance on 2021-05-11. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K202973.
When did HANAROSTENT Benefit Biliary (NNN) receive FDA 510(k) clearance?
HANAROSTENT Benefit Biliary (NNN) received FDA 510(k) clearance on 2021-05-11, under 510(k) number K202973.
Who is the listed applicant for HANAROSTENT Benefit Biliary (NNN)?
The FDA 510(k) record lists M.I.Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HANAROSTENT Benefit Biliary (NNN)?
The FDA product code for HANAROSTENT Benefit Biliary (NNN) is FGE.
相关临床试验
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列明M.I.Tech Co., Ltd.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。
相关器械（代码：FGE）
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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