Minitube 齒科Dentasleeve保護隔離袖
K 號：K211026 · 2021-08-03
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器材摘要
Minitube Dentasleeve Protective Barrier Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Minitube AB. It received FDA 510(k) clearance on 2021-08-03 under 510(k) number K211026. 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 Minitube Dentasleeve Protective Barrier Sleeves?
Minitube Dentasleeve Protective Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Minitube AB. The 510(k) number is K211026.
When did Minitube Dentasleeve Protective Barrier Sleeves receive FDA 510(k) clearance?
Minitube Dentasleeve Protective Barrier Sleeves received FDA 510(k) clearance on 2021-08-03, under 510(k) number K211026.
Who is the listed applicant for Minitube Dentasleeve Protective Barrier Sleeves?
The FDA 510(k) record lists Minitube AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Minitube Dentasleeve Protective Barrier Sleeves?
The FDA product code for Minitube Dentasleeve Protective Barrier 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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