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FDA 510(k)

CUSA 清晰超聲手術吸引器系統

K 號:K230427 · 2023-07-11

決定日期2023-07-11
產品代碼LFL
決定相當於

器材摘要

CUSA Clarity Ultrasonic Surgical Aspirator System is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2023-07-11 under 510(k) number K230427. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常見問題

What is the CUSA Clarity Ultrasonic Surgical Aspirator System?

CUSA Clarity Ultrasonic Surgical Aspirator System is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K230427.

When did CUSA Clarity Ultrasonic Surgical Aspirator System receive FDA 510(k) clearance?

CUSA Clarity Ultrasonic Surgical Aspirator System received FDA 510(k) clearance on 2023-07-11, under 510(k) number K230427.

Who is the listed applicant for CUSA Clarity Ultrasonic Surgical Aspirator System?

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

What is the FDA product code for CUSA Clarity Ultrasonic Surgical Aspirator System?

The FDA product code for CUSA Clarity Ultrasonic Surgical Aspirator System is LFL.

相關臨床試驗

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其他以 Integra LifeSciences Corporation 為申請人之記錄

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相關器械(代碼:LFL)

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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