CushionCast 可塑垫
K号: K162265 · 2016-11-15
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器械摘要
CushionCast Moldable Cushions is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical Products, LLC. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162265. 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 CushionCast Moldable Cushions?
CushionCast Moldable Cushions is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Izi Medical Products, LLC. The 510(k) number is K162265.
When did CushionCast Moldable Cushions receive FDA 510(k) clearance?
CushionCast Moldable Cushions received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162265.
Who is the listed applicant for CushionCast Moldable Cushions?
The FDA 510(k) record lists Izi Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CushionCast Moldable Cushions?
The FDA product code for CushionCast Moldable Cushions is IYE.
相关临床试验
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列明Izi Medical Products, 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：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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