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FDA 510(k)

雙氧脂生物活性玻璃泡沫

K 號:K170917 · 2017-10-30

決定日期2017-10-30
產品代碼MQV
諮詢委員會或
決定相當於

器材摘要

Bi-Ostetic Bioactive Glass Foam is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K170917. 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 Bi-Ostetic Bioactive Glass Foam?

Bi-Ostetic Bioactive Glass Foam is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Berkeley Advanced Biomaterials. The 510(k) number is K170917.

When did Bi-Ostetic Bioactive Glass Foam receive FDA 510(k) clearance?

Bi-Ostetic Bioactive Glass Foam received FDA 510(k) clearance on 2017-10-30, under 510(k) number K170917.

Who is the listed applicant for Bi-Ostetic Bioactive Glass Foam?

FDA 510(k) 記錄將 Berkeley Advanced Biomaterials 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Bi-Ostetic Bioactive Glass Foam?

The FDA product code for Bi-Ostetic Bioactive Glass Foam is MQV.

相關臨床試驗

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其他以 Berkeley Advanced Biomaterials 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: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。

官方來源

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