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FDA 510(k)

異種移植牛骨微粒

K 號:K240133 · 2024-08-16

決定日期2024-08-16
產品代碼NPM
諮詢委員會DE
決定相當於

器材摘要

Xenograft Bovine Bone Particulate is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Solutions, LLC. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240133. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xenograft Bovine Bone Particulate?

Xenograft Bovine Bone Particulate is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Collagen Solutions, LLC. The 510(k) number is K240133.

When did Xenograft Bovine Bone Particulate receive FDA 510(k) clearance?

Xenograft Bovine Bone Particulate received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240133.

Who is the listed applicant for Xenograft Bovine Bone Particulate?

The FDA 510(k) record lists Collagen Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenograft Bovine Bone Particulate?

The FDA product code for Xenograft Bovine Bone Particulate is NPM.

相關臨床試驗

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相關器械(代碼:NPM)

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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