合心保合成硫酸鈣
K 號：K250141 · 2025-05-16
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器材摘要
Synthecure Synthetic Calcium Sulfate is the device name listed in this FDA 510(k) record. The listed applicant is Austin Medical Ventures, Inc.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K250141. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Synthecure Synthetic Calcium Sulfate?
Synthecure Synthetic Calcium Sulfate is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Austin Medical Ventures, Inc.. The 510(k) number is K250141.
When did Synthecure Synthetic Calcium Sulfate receive FDA 510(k) clearance?
Synthecure Synthetic Calcium Sulfate received FDA 510(k) clearance on 2025-05-16, under 510(k) number K250141.
Who is the listed applicant for Synthecure Synthetic Calcium Sulfate?
The FDA 510(k) record lists Austin Medical Ventures, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Synthecure Synthetic Calcium Sulfate?
The FDA product code for Synthecure Synthetic Calcium Sulfate is MQV.
相關臨床試驗
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相關器械（代碼：MQV）
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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