BioZorb Marker GOLD / LP Marker GOLD
K号: K171467 · 2017-11-09
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器械摘要
BioZorb Marker GOLD / LP Marker GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Focal Therapeutics. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K171467. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BioZorb Marker GOLD / LP Marker GOLD?
BioZorb Marker GOLD / LP Marker GOLD is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Focal Therapeutics. The 510(k) number is K171467.
When did BioZorb Marker GOLD / LP Marker GOLD receive FDA 510(k) clearance?
BioZorb Marker GOLD / LP Marker GOLD received FDA 510(k) clearance on 2017-11-09, under 510(k) number K171467.
Who is the listed applicant for BioZorb Marker GOLD / LP Marker GOLD?
The FDA 510(k) record lists Focal Therapeutics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioZorb Marker GOLD / LP Marker GOLD?
The FDA product code for BioZorb Marker GOLD / LP Marker GOLD is IYE.
相关临床试验
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列明Focal Therapeutics为申报人的其他记录
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相关器械（代码：IYE）
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
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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