FDA 510(k)

MENTOR® CPX®4 PLUS增强型乳房组织扩张器

K号: K241918 · 2024-08-02

决定日期2024-08-02

产品代码LCJ

决定实质等同

器械摘要

MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241918. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander?

MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K241918.

When did MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander receive FDA 510(k) clearance?

MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241918.

Who is the listed applicant for MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander?

The FDA 510(k) record lists Mentor Worldwide, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander?

The FDA product code for MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is LCJ.

列明Mentor Worldwide, LLC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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官方来源

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