SiO2 镀层注射器 3 ml
K号: K153553 · 2016-05-17
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决定日期2016-05-17
产品代码FMF
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
SiO2 Coated syringe 3 ml is the device name listed in this FDA 510(k) record. The listed applicant is Sio2 Medical Products. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K153553. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SiO2 Coated syringe 3 ml?
SiO2 Coated syringe 3 ml is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Sio2 Medical Products. The 510(k) number is K153553.
When did SiO2 Coated syringe 3 ml receive FDA 510(k) clearance?
SiO2 Coated syringe 3 ml received FDA 510(k) clearance on 2016-05-17, under 510(k) number K153553.
Who is the listed applicant for SiO2 Coated syringe 3 ml?
The FDA 510(k) record lists Sio2 Medical Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SiO2 Coated syringe 3 ml?
The FDA product code for SiO2 Coated syringe 3 ml is FMF.
相关临床试验
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：FMF）
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
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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