FiteBac 抗菌腔道清洁剂
K号: K200614 · 2020-06-25
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决定日期2020-06-25
产品代码LBH
咨询委员会DE
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决定实质等同
器械摘要
FiteBac Antimicrobial Cavity Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Largent Health, LLC. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200614. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FiteBac Antimicrobial Cavity Cleanser?
FiteBac Antimicrobial Cavity Cleanser is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Largent Health, LLC. The 510(k) number is K200614.
When did FiteBac Antimicrobial Cavity Cleanser receive FDA 510(k) clearance?
FiteBac Antimicrobial Cavity Cleanser received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200614.
Who is the listed applicant for FiteBac Antimicrobial Cavity Cleanser?
The FDA 510(k) record lists Largent Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FiteBac Antimicrobial Cavity Cleanser?
The FDA product code for FiteBac Antimicrobial Cavity Cleanser is LBH.
相关临床试验
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列明Largent Health, LLC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：LBH）
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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