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FDA 510(k)

Ace醫學外科儀器

K 號：K200387 · 2020-07-21

申請人Ace Medical
決定日期2020-07-21
產品代碼HAE
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

Ace Medical Surgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical. It received FDA 510(k) clearance on 2020-07-21 under 510(k) number K200387. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ace Medical Surgical Instruments?

Ace Medical Surgical Instruments is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Ace Medical. The 510(k) number is K200387.

When did Ace Medical Surgical Instruments receive FDA 510(k) clearance?

Ace Medical Surgical Instruments received FDA 510(k) clearance on 2020-07-21, under 510(k) number K200387.

Who is the listed applicant for Ace Medical Surgical Instruments?

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

What is the FDA product code for Ace Medical Surgical Instruments?

The FDA product code for Ace Medical Surgical Instruments is HAE.

相關臨床試驗

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相關器械（代碼：HAE）

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。

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官方來源

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