Plasdent 一次性屏障袖套及屏障膠膜
K 號：K201604 · 2020-12-23
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器材摘要
Plasdent Disposable Barrier Sleeves and Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Plasdent Corporation. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K201604. 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 Plasdent Disposable Barrier Sleeves and Barrier Film?
Plasdent Disposable Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Plasdent Corporation. The 510(k) number is K201604.
When did Plasdent Disposable Barrier Sleeves and Barrier Film receive FDA 510(k) clearance?
Plasdent Disposable Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2020-12-23, under 510(k) number K201604.
Who is the listed applicant for Plasdent Disposable Barrier Sleeves and Barrier Film?
The FDA 510(k) record lists Plasdent Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film?
The FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film is PEM.
相關臨床試驗
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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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