卡利斯奥斯特伦塔™ 口腔支架
K号: K232293 · 2023-12-22
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器械摘要
kallisio stentra™ oral stent is the device name listed in this FDA 510(k) record. The listed applicant is Kallisio, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232293. 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 kallisio stentra™ oral stent?
kallisio stentra™ oral stent is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Kallisio, Inc.. The 510(k) number is K232293.
When did kallisio stentra™ oral stent receive FDA 510(k) clearance?
kallisio stentra™ oral stent received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232293.
Who is the listed applicant for kallisio stentra™ oral stent?
The FDA 510(k) record lists Kallisio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for kallisio stentra™ oral stent?
The FDA product code for kallisio stentra™ oral stent is IYE.
相关临床试验
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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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