FDA 510(k)

R&D 系列Nova Compo N

K号: K192178 · 2019-12-20

申请人Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

决定日期2019-12-20

产品代码EBF

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决定实质等同

器械摘要

R&D Series Nova Compo N is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192178. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the R&D Series Nova Compo N?

R&D Series Nova Compo N is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K192178.

When did R&D Series Nova Compo N receive FDA 510(k) clearance?

R&D Series Nova Compo N received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192178.

Who is the listed applicant for R&D Series Nova Compo N?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R&D Series Nova Compo N?

The FDA product code for R&D Series Nova Compo N is EBF.

列明Imicryl Dis Malzemeleri Sanayi VE Ticaret AS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。

K213609NOVA RESIN 双固化，自粘树脂水泥 K220077IMICRYL 复合材料，复合材料流动材料 K210473Nova Glass水泥（Nova Glass L，Nova Glass F，Nova Glass LC，Nova Glass BF，Nova Glass L Plus）K192913R&D 系列Nova Compo-B Plus 瓶，R&D 系列Nova Compo-B Plus 单剂量

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