FDA 510(k)

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

K 號：K201533 · 2021-03-01

決定日期2021-03-01

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Avinent Implant System S.L.U. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260527臉部4D調整器 K191566Avinent Surgical Tray

相關器械（代碼：KCT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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