OptiBond eXTRa 適用型
K 號：K182162 · 2018-11-07
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器材摘要
OptiBond eXTRa Universal is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2018-11-07 under 510(k) number K182162. 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 OptiBond eXTRa Universal?
OptiBond eXTRa Universal is a medical device that received FDA 510(k) clearance on 2018-11-07. The listed applicant is Kerr Corporation. The 510(k) number is K182162.
When did OptiBond eXTRa Universal receive FDA 510(k) clearance?
OptiBond eXTRa Universal received FDA 510(k) clearance on 2018-11-07, under 510(k) number K182162.
Who is the listed applicant for OptiBond eXTRa Universal?
The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OptiBond eXTRa Universal?
The FDA product code for OptiBond eXTRa Universal is KLE.
相關臨床試驗
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其他以 Kerr Corporation 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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