FDA 510(k)

Motiva Flora SmoothSilk组织扩张器

K号: K211676 · 2023-10-13

决定日期2023-10-13

产品代码LCJ

决定Substantially Equivalent

器械摘要

Motiva Flora SmoothSilk Tissue Expander is the device name listed in this FDA 510(k) record. The listed applicant is Motiva USA, LLC. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K211676. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the Motiva Flora SmoothSilk Tissue Expander?

Motiva Flora SmoothSilk Tissue Expander is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Motiva USA, LLC. The 510(k) number is K211676.

When did Motiva Flora SmoothSilk Tissue Expander receive FDA 510(k) clearance?

Motiva Flora SmoothSilk Tissue Expander received FDA 510(k) clearance on 2023-10-13, under 510(k) number K211676.

Who is the listed applicant for Motiva Flora SmoothSilk Tissue Expander?

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

What is the FDA product code for Motiva Flora SmoothSilk Tissue Expander?

The FDA product code for Motiva Flora SmoothSilk Tissue Expander is LCJ.

列明Motiva USA, 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。

K183163一次性、无菌、硅胶乳房测量器Motiva植入矩阵

官方来源

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