羅蒂烏生物可吸收繩
K 號：K183236 · 2019-03-11
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器材摘要
Rotium Bioresorbable Wick is the device name listed in this FDA 510(k) record. The listed applicant is Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K183236. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Rotium Bioresorbable Wick?
Rotium Bioresorbable Wick is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Nanofiber Solutions, LLC. The 510(k) number is K183236.
When did Rotium Bioresorbable Wick receive FDA 510(k) clearance?
Rotium Bioresorbable Wick received FDA 510(k) clearance on 2019-03-11, under 510(k) number K183236.
Who is the listed applicant for Rotium Bioresorbable Wick?
The FDA 510(k) record lists Nanofiber Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rotium Bioresorbable Wick?
The FDA product code for Rotium Bioresorbable Wick is MAI.
相關臨床試驗
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其他以 Nanofiber Solutions, LLC 為申請人之記錄
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：MAI）
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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