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FDA 510(k)

Jewel精準可重用硬質消毒容器系統

K 號：K162600 · 2016-12-09

申請人Jewel Precision Sheet Metal & Machine, Inc.
決定日期2016-12-09
產品代碼KCT
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Jewel Precision Reusable Rigid Sterilization Container System is the device name listed in this FDA 510(k) record. The listed applicant is Jewel Precision Sheet Metal & Machine, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162600. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Jewel Precision Reusable Rigid Sterilization Container System?

Jewel Precision Reusable Rigid Sterilization Container System is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Jewel Precision Sheet Metal & Machine, Inc.. The 510(k) number is K162600.

When did Jewel Precision Reusable Rigid Sterilization Container System receive FDA 510(k) clearance?

Jewel Precision Reusable Rigid Sterilization Container System received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162600.

Who is the listed applicant for Jewel Precision Reusable Rigid Sterilization Container System?

The FDA 510(k) record lists Jewel Precision Sheet Metal & Machine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jewel Precision Reusable Rigid Sterilization Container System?

The FDA product code for Jewel Precision Reusable Rigid Sterilization Container System is KCT.

相關臨床試驗

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相關器械（代碼：KCT）

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。

K253988LiteSet 盤子Nobel Biocare ABK261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel SurgicalK252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋DePuy Mitek, Inc.

官方來源

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