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FDA 510(k)

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K 號:K202269 · 2020-11-25

決定日期2020-11-25
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

PRE-MILLED Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Mit Global Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K202269. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PRE-MILLED Abutment?

PRE-MILLED Abutment is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Mit Global Co., Ltd.. The 510(k) number is K202269.

When did PRE-MILLED Abutment receive FDA 510(k) clearance?

PRE-MILLED Abutment received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202269.

Who is the listed applicant for PRE-MILLED Abutment?

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

What is the FDA product code for PRE-MILLED Abutment?

The FDA product code for PRE-MILLED Abutment is NHA.

相關臨床試驗

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相關器械(代碼:NHA)

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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