卡利斯奧斯滕拉™ 口腔支架
K 號：K232293 · 2023-12-22
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器材摘要
kallisio stentra™ oral stent is the device name listed in this FDA 510(k) record. The listed applicant is Kallisio, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232293. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the kallisio stentra™ oral stent?
kallisio stentra™ oral stent is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Kallisio, Inc.. The 510(k) number is K232293.
When did kallisio stentra™ oral stent receive FDA 510(k) clearance?
kallisio stentra™ oral stent received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232293.
Who is the listed applicant for kallisio stentra™ oral stent?
The FDA 510(k) record lists Kallisio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for kallisio stentra™ oral stent?
The FDA product code for kallisio stentra™ oral stent is IYE.
相關臨床試驗
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相關器械（代碼：IYE）
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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