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FDA 510(k)

Vesseal

K 號:K221280 · 2022-12-09

決定日期2022-12-09
產品代碼GAW
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

Vesseal is the device name listed in this FDA 510(k) record. The listed applicant is Lydus Medical , Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K221280. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vesseal?

Vesseal is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Lydus Medical , Ltd.. The 510(k) number is K221280.

When did Vesseal receive FDA 510(k) clearance?

Vesseal received FDA 510(k) clearance on 2022-12-09, under 510(k) number K221280.

Who is the listed applicant for Vesseal?

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

What is the FDA product code for Vesseal?

The FDA product code for Vesseal is GAW.

相關臨床試驗

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相關器械(代碼:GAW)

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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