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FDA 510(k)

Natrelle 133S 组织扩张器

K号: K254126 · 2026-01-16

申请人AbbVie
决定日期2026-01-16
产品代码LCJ
决定实质等同

器械摘要

Natrelle 133S Tissue Expanders is the device name listed in this FDA 510(k) record. The listed applicant is AbbVie. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K254126. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the Natrelle 133S Tissue Expanders?

Natrelle 133S Tissue Expanders is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is AbbVie. The 510(k) number is K254126.

When did Natrelle 133S Tissue Expanders receive FDA 510(k) clearance?

Natrelle 133S Tissue Expanders received FDA 510(k) clearance on 2026-01-16, under 510(k) number K254126.

Who is the listed applicant for Natrelle 133S Tissue Expanders?

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

What is the FDA product code for Natrelle 133S Tissue Expanders?

The FDA product code for Natrelle 133S Tissue Expanders is LCJ.

相关临床试验

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相关器械(代码:LCJ)

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。

官方来源

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