Visalys CemCore, Visalys Cem Core 尝試膠膠
K 號：K191527 · 2019-11-08
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器材摘要
Visalys CemCore, Visalys Cem Core Try In Paste is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191527. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Visalys CemCore, Visalys Cem Core Try In Paste?
Visalys CemCore, Visalys Cem Core Try In Paste is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K191527.
When did Visalys CemCore, Visalys Cem Core Try In Paste receive FDA 510(k) clearance?
Visalys CemCore, Visalys Cem Core Try In Paste received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191527.
Who is the listed applicant for Visalys CemCore, Visalys Cem Core Try In Paste?
FDA 510(k) 記錄將Kettenbach GmbH & Co. KG列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Visalys CemCore, Visalys Cem Core Try In Paste?
The FDA product code for Visalys CemCore, Visalys Cem Core Try In Paste is EMA.
相關臨床試驗
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其他以 Kettenbach GmbH & Co. KG 為申請人之記錄
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相關器械（代碼：EMA）
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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