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FDA 510(k)

TN-刷

K 號:K170596 · 2017-09-11

決定日期2017-09-11
產品代碼ELB
諮詢委員會DE
決定相當於

器材摘要

TN-Brush 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 2017-09-11 under 510(k) number K170596. The device is classified under product code ELB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TN-Brush?

TN-Brush is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K170596.

When did TN-Brush receive FDA 510(k) clearance?

TN-Brush received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170596.

Who is the listed applicant for TN-Brush?

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 TN-Brush?

The FDA product code for TN-Brush is ELB.

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其他以 Genoss Co., Ltd. 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。

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