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FDA 510(k)

GingiKnit+、GingiBraid+ 及搭配GingiBraid+ 非浸潤收縮繩的Shortcut

K 號：K162164 · 2017-01-13

申請人Kerr Corporation
決定日期2017-01-13
產品代碼MVL
決定相當於

器材摘要

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K162164. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

常見問題

What is the GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord?

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Kerr Corporation. The 510(k) number is K162164.

When did GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord receive FDA 510(k) clearance?

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord received FDA 510(k) clearance on 2017-01-13, under 510(k) number K162164.

Who is the listed applicant for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord?

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

What is the FDA product code for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord?

The FDA product code for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord is MVL.

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其他以 Kerr Corporation 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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相關器械（代碼：MVL）

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。

K254239CyClean 線SS GLOBALK253797一站式Mediclus Co., Ltd.K243910RetraxilKulzer, LLCK211420靜脈血栓形成治療凝胶Belport Company, Inc., Gingi-PakK211419Gingi-Aid GelBelport Company, Inc., Gingi-PakK213149VOCO 收縮膠Voco GmbH

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