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FDA 510(k)

SuperCable® 等電性環繞系統

K 號:K181749 · 2018-08-01

決定日期2018-08-01
產品代碼JDQ
諮詢委員會或
決定相當於

器材摘要

SuperCable® Iso-Elastic™ Cerclage System is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Incorporated. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K181749. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SuperCable® Iso-Elastic™ Cerclage System?

SuperCable® Iso-Elastic™ Cerclage System is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Kinamed, Incorporated. The 510(k) number is K181749.

When did SuperCable® Iso-Elastic™ Cerclage System receive FDA 510(k) clearance?

SuperCable® Iso-Elastic™ Cerclage System received FDA 510(k) clearance on 2018-08-01, under 510(k) number K181749.

Who is the listed applicant for SuperCable® Iso-Elastic™ Cerclage System?

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

What is the FDA product code for SuperCable® Iso-Elastic™ Cerclage System?

The FDA product code for SuperCable® Iso-Elastic™ Cerclage System is JDQ.

相關臨床試驗

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相關器械(代碼:JDQ)

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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