牙科阻隔器和套管
K 號：K233918 · 2024-05-09
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決定日期2024-05-09
產品代碼PEM
諮詢委員會SU
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決定相當於
器材摘要
Dental Barrier and Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Yongqing Huaguan Dental Instruments Factory. It received FDA 510(k) clearance on 2024-05-09 under 510(k) number K233918. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dental Barrier and Sleeves?
Dental Barrier and Sleeves is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Yongqing Huaguan Dental Instruments Factory. The 510(k) number is K233918.
When did Dental Barrier and Sleeves receive FDA 510(k) clearance?
Dental Barrier and Sleeves received FDA 510(k) clearance on 2024-05-09, under 510(k) number K233918.
Who is the listed applicant for Dental Barrier and Sleeves?
The FDA 510(k) record lists Yongqing Huaguan Dental Instruments Factory as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Barrier and Sleeves?
The FDA product code for Dental Barrier and Sleeves is PEM.
相關臨床試驗
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：PEM）
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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