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FDA 510(k)

WoundClot9

K 號:K160679 · 2016-08-08

決定日期2016-08-08
產品代碼QSY
決定相當於

器材摘要

WoundClot9 is the device name listed in this FDA 510(k) record. The listed applicant is Core Scientific Creation , Ltd.. It received FDA 510(k) clearance on 2016-08-08 under 510(k) number K160679. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常見問題

What is the WoundClot9?

WoundClot9 is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Core Scientific Creation , Ltd.. The 510(k) number is K160679.

When did WoundClot9 receive FDA 510(k) clearance?

WoundClot9 received FDA 510(k) clearance on 2016-08-08, under 510(k) number K160679.

Who is the listed applicant for WoundClot9?

The FDA 510(k) record lists Core Scientific Creation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WoundClot9?

The FDA product code for WoundClot9 is QSY.

相關臨床試驗

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相關器械(代碼:QSY)

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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