亮結合大眾
K 號：K200153 · 2020-10-28
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器材摘要
Bright Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K200153. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bright Bond Universal?
Bright Bond Universal is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K200153.
When did Bright Bond Universal receive FDA 510(k) clearance?
Bright Bond Universal received FDA 510(k) clearance on 2020-10-28, under 510(k) number K200153.
Who is the listed applicant for Bright Bond Universal?
The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bright Bond Universal?
The FDA product code for Bright Bond Universal is KLE.
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其他以 Genoss Co., Ltd. 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。
相關器械（代碼：KLE）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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