FDA 510(k)

Neodent Instrument Kit Cases

K番号: K192670 · 2019-12-18

申請者Jjgc Industria E Comercio DE Materiais Dentarios S.A.

決定日2019-12-18

製品コードKCT

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定Substantially Equivalent

医療機器の概要

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 2019-12-18 under 510(k) number K192670. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Neodent Instrument Kit Cases?

Neodent Instrument Kit Cases is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K192670.

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

Neodent Instrument Kit Cases received FDA 510(k) clearance on 2019-12-18, under 510(k) number K192670.

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.

申請者としてJjgc Industria E Comercio DE Materiais Dentarios S.A.を記載するその他の記録

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