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FDA 510(k)

FineEtch(FineEtch-10 1.2ml、FineEtch-10 5ml、FineEtch-37 1.2ml FineEtch-37 5ml、FineEtch 37% 1.2ml 20入包)

K 號:K242675 · 2024-11-01

決定日期2024-11-01
產品代碼KLE
諮詢委員會DE
決定相當於

器材摘要

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242675. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)?

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Spident Co., Ltd.. The 510(k) number is K242675.

When did FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) receive FDA 510(k) clearance?

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242675.

Who is the listed applicant for FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)?

FDA 510(k) 記錄將 Spident Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)?

The FDA product code for FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is KLE.

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其他以 Spident Co., Ltd. 為申請人之記錄

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相關器械(代碼:KLE)

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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