Caprolon
K号: K181320 · 2018-09-18
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决定日期2018-09-18
产品代码GAM
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Caprolon is the device name listed in this FDA 510(k) record. The listed applicant is Resorba Medical GmbH. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181320. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Caprolon?
Caprolon is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Resorba Medical GmbH. The 510(k) number is K181320.
When did Caprolon receive FDA 510(k) clearance?
Caprolon received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181320.
Who is the listed applicant for Caprolon?
The FDA 510(k) record lists Resorba Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Caprolon?
The FDA product code for Caprolon is GAM.
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相关器械（代码：GAM）
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。
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官方来源
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