FDA 510(k)

KJ 鑫隆陶瓷植入系統

K 號：K173116 · 2018-06-28

決定日期2018-06-28

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

KJ ZIRCONIA Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Kj Meditech Co., Ltd.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K173116. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KJ ZIRCONIA Implant System?

KJ ZIRCONIA Implant System is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Kj Meditech Co., Ltd.. The 510(k) number is K173116.

When did KJ ZIRCONIA Implant System receive FDA 510(k) clearance?

KJ ZIRCONIA Implant System received FDA 510(k) clearance on 2018-06-28, under 510(k) number K173116.

Who is the listed applicant for KJ ZIRCONIA Implant System?

The FDA 510(k) record lists Kj Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KJ ZIRCONIA Implant System?

The FDA product code for KJ ZIRCONIA Implant System is DZE.

其他以 Kj Meditech Co., Ltd. 為申請人之記錄

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相關器械（代碼：DZE）

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官方來源

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