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FDA 510(k)

TruAbutment DS

K 號:K170259 · 2017-05-25

申請人Truabutment
決定日期2017-05-25
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

TruAbutment DS is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170259. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TruAbutment DS?

TruAbutment DS is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is Truabutment. The 510(k) number is K170259.

When did TruAbutment DS receive FDA 510(k) clearance?

TruAbutment DS received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170259.

Who is the listed applicant for TruAbutment DS?

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

What is the FDA product code for TruAbutment DS?

The FDA product code for TruAbutment DS is NHA.

相關臨床試驗

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其他以 Truabutment 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:NHA)

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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