高强度缝合线
K号: K192637 · 2020-03-02
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决定日期2020-03-02
产品代码GAT
咨询委员会SU
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决定实质等同
器械摘要
High Strength Suture is the device name listed in this FDA 510(k) record. The listed applicant is Yunyi (Beijing) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K192637. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the High Strength Suture?
High Strength Suture is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Yunyi (Beijing) Medical Device Co., Ltd.. The 510(k) number is K192637.
When did High Strength Suture receive FDA 510(k) clearance?
High Strength Suture received FDA 510(k) clearance on 2020-03-02, under 510(k) number K192637.
Who is the listed applicant for High Strength Suture?
The FDA 510(k) record lists Yunyi (Beijing) Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for High Strength Suture?
The FDA product code for High Strength Suture is GAT.
相关临床试验
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列明Yunyi (Beijing) Medical Device Co., Ltd.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：GAT）
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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