非无菌氧化鋁塊
K 號：K190112 · 2019-12-20
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器材摘要
Non-Sterile Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Fine Advanced Compound Co., Ltd.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190112. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Non-Sterile Zirconia Block?
Non-Sterile Zirconia Block is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Fine Advanced Compound Co., Ltd.. The 510(k) number is K190112.
When did Non-Sterile Zirconia Block receive FDA 510(k) clearance?
Non-Sterile Zirconia Block received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190112.
Who is the listed applicant for Non-Sterile Zirconia Block?
The FDA 510(k) record lists Fine Advanced Compound Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Non-Sterile Zirconia Block?
The FDA product code for Non-Sterile Zirconia Block is EIH.
相關臨床試驗
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相關器械（代碼：EIH）
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
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