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FDA 510(k)

普通及整形外科器械

K 號:K152400 · 2016-01-22

決定日期2016-01-22
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

General & Plastic Surgery Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Sontec Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152400. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the General & Plastic Surgery Instruments?

General & Plastic Surgery Instruments is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Sontec Instruments, Inc.. The 510(k) number is K152400.

When did General & Plastic Surgery Instruments receive FDA 510(k) clearance?

General & Plastic Surgery Instruments received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152400.

Who is the listed applicant for General & Plastic Surgery Instruments?

The FDA 510(k) record lists Sontec Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for General & Plastic Surgery Instruments?

The FDA product code for General & Plastic Surgery Instruments is GCJ.

相關臨床試驗

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相關器械(代碼:GCJ)

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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