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FDA 510(k)

PMSSteripack平面灭菌袋（FP）和卷（FL）带化学指示剂

K号: K162362 · 2017-10-13

申请人Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
决定日期2017-10-13
产品代码FRG
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

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K162362. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. The 510(k) number is K162362.

When did PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator receive FDA 510(k) clearance?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator received FDA 510(k) clearance on 2017-10-13, under 510(k) number K162362.

Who is the listed applicant for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

The FDA 510(k) record lists Pms Tibbi Cihazlar Teknolojisi San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

The FDA product code for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is FRG.

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：FRG）

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。

K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术O&M Halyard, Inc.K252823Dukal 烫金纸灭菌包装Dukal, LLCK253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹O&M Halyard, Inc.K251347灭菌袋/卷Sterivic Medical Co., Ltd.K251177自封灭菌袋和卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

官方来源

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