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FDA 510(k)

史密斯與內夫藥品應用表

K 號:K190367 · 2019-05-21

決定日期2019-05-21
產品代碼QGY
諮詢委員會GU
決定相當於

器材摘要

Smith & Nephew Tablet Application is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K190367. The device is classified under product code QGY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smith & Nephew Tablet Application?

Smith & Nephew Tablet Application is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Smith & Nephew. The 510(k) number is K190367.

When did Smith & Nephew Tablet Application receive FDA 510(k) clearance?

Smith & Nephew Tablet Application received FDA 510(k) clearance on 2019-05-21, under 510(k) number K190367.

Who is the listed applicant for Smith & Nephew Tablet Application?

The FDA 510(k) record lists Smith & Nephew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smith & Nephew Tablet Application?

The FDA product code for Smith & Nephew Tablet Application is QGY.

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其他以 Smith & Nephew 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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