FDA 510(k)

Ritleng®+ 和 Ritleng®+ PVP

K号: K201892 · 2021-03-11

申请人Fci (France Chirurgie Instrumentation) Sas

决定日期2021-03-11

产品代码OKS

决定实质等同

器械摘要

Ritleng®+ and Ritleng®+ PVP is the device name listed in this FDA 510(k) record. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. It received FDA 510(k) clearance on 2021-03-11 under 510(k) number K201892. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

常见问题

What is the Ritleng®+ and Ritleng®+ PVP?

Ritleng®+ and Ritleng®+ PVP is a medical device that received FDA 510(k) clearance on 2021-03-11. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K201892.

When did Ritleng®+ and Ritleng®+ PVP receive FDA 510(k) clearance?

Ritleng®+ and Ritleng®+ PVP received FDA 510(k) clearance on 2021-03-11, under 510(k) number K201892.

Who is the listed applicant for Ritleng®+ and Ritleng®+ PVP?

The FDA 510(k) record lists Fci (France Chirurgie Instrumentation) Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ritleng®+ and Ritleng®+ PVP?

The FDA product code for Ritleng®+ and Ritleng®+ PVP is OKS.

列明Fci (France Chirurgie Instrumentation) Sas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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