FDA 510(k)

CooperSurgical Milex® 子宫托

K号: K250438 · 2025-04-11

决定日期2025-04-11

产品代码HHW

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决定实质等同

器械摘要

CooperSurgical Milex® Pessaries is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250438. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CooperSurgical Milex® Pessaries?

CooperSurgical Milex® Pessaries is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K250438.

When did CooperSurgical Milex® Pessaries receive FDA 510(k) clearance?

CooperSurgical Milex® Pessaries received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250438.

Who is the listed applicant for CooperSurgical Milex® Pessaries?

FDA 510(k)记录中列出CooperSurgical, Inc.为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for CooperSurgical Milex® Pessaries?

The FDA product code for CooperSurgical Milex® Pessaries is HHW.

列明CooperSurgical, Inc.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。

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