Twilite 设备
K号: K190687 · 2019-07-02
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决定日期2019-07-02
产品代码LRK
咨询委员会DE
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决定实质等同
器械摘要
Twilite Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Stephen J Harkins, Dds, PC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190687. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Twilite Appliance?
Twilite Appliance is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Stephen J Harkins, Dds, PC. The 510(k) number is K190687.
When did Twilite Appliance receive FDA 510(k) clearance?
Twilite Appliance received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190687.
Who is the listed applicant for Twilite Appliance?
The FDA 510(k) record lists Stephen J Harkins, Dds, PC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Twilite Appliance?
The FDA product code for Twilite Appliance is LRK.
相关临床试验
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：LRK）
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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