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FDA 510(k)

SIC收縮型 & SICvantage收縮型

K 號:K210489 · 2022-03-17

申請人Sic Invent AG
決定日期2022-03-17
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

SICtapered & SICvantage tapered is the device name listed in this FDA 510(k) record. The listed applicant is Sic Invent AG. It received FDA 510(k) clearance on 2022-03-17 under 510(k) number K210489. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SICtapered & SICvantage tapered?

SICtapered & SICvantage tapered is a medical device that received FDA 510(k) clearance on 2022-03-17. The listed applicant is Sic Invent AG. The 510(k) number is K210489.

When did SICtapered & SICvantage tapered receive FDA 510(k) clearance?

SICtapered & SICvantage tapered received FDA 510(k) clearance on 2022-03-17, under 510(k) number K210489.

Who is the listed applicant for SICtapered & SICvantage tapered?

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

What is the FDA product code for SICtapered & SICvantage tapered?

The FDA product code for SICtapered & SICvantage tapered is DZE.

相關臨床試驗

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其他以 Sic Invent AG 為申請人之記錄

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。

相關器械(代碼:DZE)

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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