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FDA 510(k)

亮印印象-亮、亮印印象-中、亮印印象-重、亮印印象-咬、亮印印象-橡皮泥

K 號:K214086 · 2022-12-15

決定日期2022-12-15
產品代碼ELW
諮詢委員會DE
決定相當於

器材摘要

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K214086. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K214086.

When did Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty receive FDA 510(k) clearance?

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty received FDA 510(k) clearance on 2022-12-15, under 510(k) number K214086.

Who is the listed applicant for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

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

What is the FDA product code for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

The FDA product code for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is ELW.

相關臨床試驗

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其他以 Genoss Co., Ltd. 為申請人之記錄

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相關器械(代碼:ELW)

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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