FDA 510(k)

アビエントバイオミミックコーラルおよびオーシャンアイスberg 消毒カセット

K番号: K201533 · 2021-03-01

決定日2021-03-01

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]

決定大幅同等

医療機器の概要

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K201533. 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 Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Avinent Implant System S.L.U.. The 510(k) number is K201533.

When did Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes receive FDA 510(k) clearance?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes received FDA 510(k) clearance on 2021-03-01, under 510(k) number K201533.

Who is the listed applicant for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

The FDA 510(k) record lists Avinent Implant System S.L.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

The FDA product code for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is KCT.

申請者としてAvinent Implant System S.L.U.を記載するその他の記録

K260527FACE4D アライナー K191566アビエント手術トレイ

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