FDA 510(k)

Versalock Mini 及 Micro 鍍金系統

K 號：K242596 · 2024-11-21

申請人GM Dos Reis Industria e Comercio Ltda.

決定日期2024-11-21

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Versalock Mini and Micro Plating System is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K242596. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Versalock Mini and Micro Plating System?

Versalock Mini and Micro Plating System is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K242596.

When did Versalock Mini and Micro Plating System receive FDA 510(k) clearance?

Versalock Mini and Micro Plating System received FDA 510(k) clearance on 2024-11-21, under 510(k) number K242596.

Who is the listed applicant for Versalock Mini and Micro Plating System?

FDA 510(k) 記錄將 GM Dos Reis Industria e Comercio Ltda. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Versalock Mini and Micro Plating System?

The FDA product code for Versalock Mini and Micro Plating System is HRS.

其他以 GM Dos Reis Industria e Comercio Ltda. 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。

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相關器械（代碼：HRS）

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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