GR-14 树脂系统
K号: K210298 · 2021-05-05
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决定日期2021-05-05
产品代码EBI
咨询委员会DE
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决定实质等同
器械摘要
GR-14 Resin System is the device name listed in this FDA 510(k) record. The listed applicant is Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2021-05-05 under 510(k) number K210298. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GR-14 Resin System?
GR-14 Resin System is a medical device that received FDA 510(k) clearance on 2021-05-05. The listed applicant is Pro3Dure Medical GmbH. The 510(k) number is K210298.
When did GR-14 Resin System receive FDA 510(k) clearance?
GR-14 Resin System received FDA 510(k) clearance on 2021-05-05, under 510(k) number K210298.
Who is the listed applicant for GR-14 Resin System?
The FDA 510(k) record lists Pro3Dure Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GR-14 Resin System?
The FDA product code for GR-14 Resin System is EBI.
相关临床试验
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列明Pro3Dure Medical GmbH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：EBI）
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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