FDA 510(k)

HANAROSTENT 頸動脈 (NNN) 好處胆道 (NNN)

K 號：K202973 · 2021-05-11

決定日期2021-05-11

產品代碼FGE

諮詢委員會GU

決定Unknown

器材摘要

HANAROSTENT Benefit Biliary (NNN) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-05-11 under 510(k) number K202973. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the HANAROSTENT Benefit Biliary (NNN)?

HANAROSTENT Benefit Biliary (NNN) is a medical device that received FDA 510(k) clearance on 2021-05-11. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K202973.

When did HANAROSTENT Benefit Biliary (NNN) receive FDA 510(k) clearance?

HANAROSTENT Benefit Biliary (NNN) received FDA 510(k) clearance on 2021-05-11, under 510(k) number K202973.

Who is the listed applicant for HANAROSTENT Benefit Biliary (NNN)?

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

What is the FDA product code for HANAROSTENT Benefit Biliary (NNN)?

The FDA product code for HANAROSTENT Benefit Biliary (NNN) is FGE.

其他以 M.I.Tech Co., Ltd. 為申請人之記錄

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相關器械（代碼：FGE）

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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