FDA 510(k)

GR-14 树脂系統

K 號：K210298 · 2021-05-05

決定日期2021-05-05

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

GR-14 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 2021-05-05 under 510(k) number K210298. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GR-14 Resin System?

GR-14 Resin System is a medical device that received FDA 510(k) clearance on 2021-05-05. The listed applicant is Pro3Dure Medical GmbH. The 510(k) number is K210298.

When did GR-14 Resin System receive FDA 510(k) clearance?

GR-14 Resin System received FDA 510(k) clearance on 2021-05-05, under 510(k) number K210298.

Who is the listed applicant for GR-14 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-14 Resin System?

The FDA product code for GR-14 Resin System is EBI.

其他以 Pro3Dure Medical GmbH 為申請人之記錄

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