FDA 510(k)

良好導電鹽溶液袋

K 號：K160801 · 2016-11-29

決定日期2016-11-29

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Well Lead Extraction Bag is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K160801. 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 Well Lead Extraction Bag?

Well Lead Extraction Bag is a medical device that received FDA 510(k) clearance on 2016-11-29. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K160801.

When did Well Lead Extraction Bag receive FDA 510(k) clearance?

Well Lead Extraction Bag received FDA 510(k) clearance on 2016-11-29, under 510(k) number K160801.

Who is the listed applicant for Well Lead Extraction Bag?

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

What is the FDA product code for Well Lead Extraction Bag?

The FDA product code for Well Lead Extraction Bag is GCJ.

其他以 Well Lead Medical Co., Ltd. 為申請人之記錄

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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。

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