GOLNIT 不可吸收 PTFE 外科缝合线
K号: K163049 · 2017-06-21
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决定日期2017-06-21
产品代码NBY
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
GOLNIT Non-Absorbable PTFE Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Antarma Dba Golnit Sutures. It received FDA 510(k) clearance on 2017-06-21 under 510(k) number K163049. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GOLNIT Non-Absorbable PTFE Surgical Suture?
GOLNIT Non-Absorbable PTFE Surgical Suture is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Antarma Dba Golnit Sutures. The 510(k) number is K163049.
When did GOLNIT Non-Absorbable PTFE Surgical Suture receive FDA 510(k) clearance?
GOLNIT Non-Absorbable PTFE Surgical Suture received FDA 510(k) clearance on 2017-06-21, under 510(k) number K163049.
Who is the listed applicant for GOLNIT Non-Absorbable PTFE Surgical Suture?
The FDA 510(k) record lists Antarma Dba Golnit Sutures as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GOLNIT Non-Absorbable PTFE Surgical Suture?
The FDA product code for GOLNIT Non-Absorbable PTFE Surgical Suture is NBY.
相关临床试验
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相关器械（代码：NBY）
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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