FDA 510(k)

Neodent 仪器套件箱

K号: K190665 · 2019-12-23

申请人Jjgc Industria E Comercio DE Materiais Dentarios S.A.

决定日期2019-12-23

产品代码KCT

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

Neodent Instrument Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K190665. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neodent Instrument Kit Cases?

Neodent Instrument Kit Cases is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K190665.

When did Neodent Instrument Kit Cases receive FDA 510(k) clearance?

Neodent Instrument Kit Cases received FDA 510(k) clearance on 2019-12-23, under 510(k) number K190665.

Who is the listed applicant for Neodent Instrument Kit Cases?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Instrument Kit Cases?

The FDA product code for Neodent Instrument Kit Cases is KCT.

列明Jjgc Industria E Comercio DE Materiais Dentarios S.A.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。

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