FDA 510(k)

GR-17 树脂系統

K 號：K201827 · 2020-11-05

決定日期2020-11-05

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

GR-17 Resin System is the device name listed in this FDA 510(k) record. The listed applicant is Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201827. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GR-17 Resin System?

GR-17 Resin System is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Pro3Dure Medical GmbH. The 510(k) number is K201827.

When did GR-17 Resin System receive FDA 510(k) clearance?

GR-17 Resin System received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201827.

Who is the listed applicant for GR-17 Resin System?

The FDA 510(k) record lists Pro3Dure Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GR-17 Resin System?

The FDA product code for GR-17 Resin System is EBG.

其他以 Pro3Dure Medical GmbH 為申請人之記錄

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相關器械（代碼：EBG）

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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