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FDA 510(k)

Neoss 個體義齒

K 號:K211396 · 2022-05-17

申請人Neoss, Ltd.
決定日期2022-05-17
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

Neoss Individual Prosthetics is the device name listed in this FDA 510(k) record. The listed applicant is Neoss, Ltd.. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K211396. 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 Neoss Individual Prosthetics?

Neoss Individual Prosthetics is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Neoss, Ltd.. The 510(k) number is K211396.

When did Neoss Individual Prosthetics receive FDA 510(k) clearance?

Neoss Individual Prosthetics received FDA 510(k) clearance on 2022-05-17, under 510(k) number K211396.

Who is the listed applicant for Neoss Individual Prosthetics?

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

What is the FDA product code for Neoss Individual Prosthetics?

The FDA product code for Neoss Individual Prosthetics 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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