Oss導引器
K 號：K200623 · 2020-10-02
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器材摘要
OssGuide is the device name listed in this FDA 510(k) record. The listed applicant is Sk Bioland Co., Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K200623. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OssGuide?
OssGuide is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Sk Bioland Co., Ltd.. The 510(k) number is K200623.
When did OssGuide receive FDA 510(k) clearance?
OssGuide received FDA 510(k) clearance on 2020-10-02, under 510(k) number K200623.
Who is the listed applicant for OssGuide?
The FDA 510(k) record lists Sk Bioland Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OssGuide?
The FDA product code for OssGuide is NPL.
相關臨床試驗
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相關器械（代碼：NPL）
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。
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官方來源
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