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K号: K201940 · 2020-12-03
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决定日期2020-12-03
产品代码DYW
咨询委员会DE
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器械摘要
Braces on Demand Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Braces on Demand, Inc.. It received FDA 510(k) clearance on 2020-12-03 under 510(k) number K201940. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Braces on Demand Bracket?
Braces on Demand Bracket is a medical device that received FDA 510(k) clearance on 2020-12-03. The listed applicant is Braces on Demand, Inc.. The 510(k) number is K201940.
When did Braces on Demand Bracket receive FDA 510(k) clearance?
Braces on Demand Bracket received FDA 510(k) clearance on 2020-12-03, under 510(k) number K201940.
Who is the listed applicant for Braces on Demand Bracket?
The FDA 510(k) record lists Braces on Demand, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Braces on Demand Bracket?
The FDA product code for Braces on Demand Bracket is DYW.
相关临床试验
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相关器械（代码：DYW）
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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