FDA 510(k)

LacriJet®

K 號：K201606 · 2020-12-18

申請人Fci (France Chirurgie Instrumentation) Sas

決定日期2020-12-18

產品代碼OKS

決定相當於

器材摘要

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.

常見問題

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.

其他以 Fci (France Chirurgie Instrumentation) Sas 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K212741EZYPOR K203569黃金針狹型重質眼瞼植入物，白金針狹型重質眼瞼植入物 K201892Ritleng®+ 及 Ritleng®+ PVP

相關器械（代碼：OKS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K201892Ritleng®+ 及 Ritleng®+ PVPFci (France Chirurgie Instrumentation) Sas K170247Lacriflow CLKaneka Pharma America, LLC K161373桿棒Fci (France Chirurgie Instrumentation)K160710Oasis 泪管導管組Anodyne

官方來源

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