FDA 510(k)

IMICRYL 复合材料，复合材料流动材料

K号: K220077 · 2022-08-09

申请人Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

决定日期2022-08-09

产品代码EBF

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决定实质等同

器械摘要

IMICRYL Composite, Composite Flow Materials 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 2022-08-09 under 510(k) number K220077. 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 IMICRYL Composite, Composite Flow Materials?

IMICRYL Composite, Composite Flow Materials is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K220077.

When did IMICRYL Composite, Composite Flow Materials receive FDA 510(k) clearance?

IMICRYL Composite, Composite Flow Materials received FDA 510(k) clearance on 2022-08-09, under 510(k) number K220077.

Who is the listed applicant for IMICRYL Composite, Composite Flow Materials?

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 IMICRYL Composite, Composite Flow Materials?

The FDA product code for IMICRYL Composite, Composite Flow Materials 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 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 K192178R&D 系列Nova Compo N

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