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FDA 510(k)

Jewel 精密可重复使用刚性灭菌容器系统

K号: K162600 · 2016-12-09

申请人Jewel Precision Sheet Metal & Machine, Inc.
决定日期2016-12-09
产品代码KCT
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：KCT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253988LiteSet托盘Nobel Biocare ABK261935外科和假肢托盘Dentsply Sirona, Inc.K253187SteriBest® 消毒托盘系统Mastel SurgicalK252854SteriTite 容器系统与 MediTray 产品Case Medical, Inc.K260726Straumann® ProClean™托盘（041.800；041.801）Institut Straumann AGK253791PUREVUE™ 快速连接导管系统托盘；PUREVUE™ 快速连接导管系统盖DePuy Mitek, Inc.

官方来源

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