FDA 510(k)

LacriJet®

K号: K201606 · 2020-12-18

申请人Fci (France Chirurgie Instrumentation) Sas

决定日期2020-12-18

产品代码OKS

决定实质等同

器械摘要

LacriJet® 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 2020-12-18 under 510(k) number K201606. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

常见问题

What is the LacriJet®?

LacriJet® is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K201606.

When did LacriJet® receive FDA 510(k) clearance?

LacriJet® received FDA 510(k) clearance on 2020-12-18, under 510(k) number K201606.

Who is the listed applicant for LacriJet®?

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 LacriJet®?

The FDA product code for LacriJet® 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。

K212741EZYPOR K203569Gold 锥形重睑植入物，铂金锥形重睑植入物 K201892Ritleng®+ 和 Ritleng®+ PVP

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