Steriking 医疗器械包装
K号: K221016 · 2022-05-05
广告
申请人Wipak OY
决定日期2022-05-05
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
Steriking Packaging for Medical Devices is the device name listed in this FDA 510(k) record. The listed applicant is Wipak OY. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221016. 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 Steriking Packaging for Medical Devices?
Steriking Packaging for Medical Devices is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Wipak OY. The 510(k) number is K221016.
When did Steriking Packaging for Medical Devices receive FDA 510(k) clearance?
Steriking Packaging for Medical Devices received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221016.
Who is the listed applicant for Steriking Packaging for Medical Devices?
The FDA 510(k) record lists Wipak OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Steriking Packaging for Medical Devices?
The FDA product code for Steriking Packaging for Medical Devices 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。
列明Wipak OY为申报人的其他记录
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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告