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FDA 510(k)

再製ArthoCare消融棒

K 號:K173741 · 2018-03-05

申請人Renovo, Inc.
決定日期2018-03-05
產品代碼NUJ
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Reprocessed ArthoCare Ablation Wand is the device name listed in this FDA 510(k) record. The listed applicant is Renovo, Inc.. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K173741. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed ArthoCare Ablation Wand?

Reprocessed ArthoCare Ablation Wand is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Renovo, Inc.. The 510(k) number is K173741.

When did Reprocessed ArthoCare Ablation Wand receive FDA 510(k) clearance?

Reprocessed ArthoCare Ablation Wand received FDA 510(k) clearance on 2018-03-05, under 510(k) number K173741.

Who is the listed applicant for Reprocessed ArthoCare Ablation Wand?

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

What is the FDA product code for Reprocessed ArthoCare Ablation Wand?

The FDA product code for Reprocessed ArthoCare Ablation Wand is NUJ.

相關臨床試驗

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其他以 Renovo, Inc. 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:NUJ)

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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