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FDA 510(k)

波爾寧實驗室肝拉開器

K 號:K243399 · 2025-07-02

決定日期2025-07-02
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Boehringer Laboratories Liver Retractor is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories, LLC. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K243399. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Boehringer Laboratories Liver Retractor?

Boehringer Laboratories Liver Retractor is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Boehringer Laboratories, LLC. The 510(k) number is K243399.

When did Boehringer Laboratories Liver Retractor receive FDA 510(k) clearance?

Boehringer Laboratories Liver Retractor received FDA 510(k) clearance on 2025-07-02, under 510(k) number K243399.

Who is the listed applicant for Boehringer Laboratories Liver Retractor?

FDA 510(k) 記錄將 Boehringer Laboratories, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Boehringer Laboratories Liver Retractor?

The FDA product code for Boehringer Laboratories Liver Retractor is GCJ.

相關臨床試驗

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其他以 Boehringer Laboratories, LLC 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:GCJ)

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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