斯泰里比特
K 號：K180949 · 2018-11-08
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器材摘要
Steribite is the device name listed in this FDA 510(k) record. The listed applicant is Rjr Surgical, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K180949. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Steribite?
Steribite is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Rjr Surgical, Inc.. The 510(k) number is K180949.
When did Steribite receive FDA 510(k) clearance?
Steribite received FDA 510(k) clearance on 2018-11-08, under 510(k) number K180949.
Who is the listed applicant for Steribite?
The FDA 510(k) record lists Rjr Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Steribite?
The FDA product code for Steribite is HAE.
相關臨床試驗
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相關器械（代碼：HAE）
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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