FDA 510(k)

RAM COR-SUTURE 快速上線外科縫線，COR-SUTURE 快速上線外科縫線

K 號：K203081 · 2020-11-24

決定日期2020-11-24

產品代碼GAS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Solutions. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K203081. The device is classified under product code GAS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture?

RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Lsi Solutions. The 510(k) number is K203081.

When did RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture receive FDA 510(k) clearance?

RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture received FDA 510(k) clearance on 2020-11-24, under 510(k) number K203081.

Who is the listed applicant for RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture?

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

What is the FDA product code for RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture?

The FDA product code for RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture is GAS.

其他以 Lsi Solutions 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。

K163639LS-5 ePTFE 緝線

相關器械（代碼：GAS）

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。

K203120RD快速上縫針，0聚酯，RD快速上縫針，2-0聚酯，RD QUCIK LOAD SUTURE，2-0聚丙烯Lsi Solutions, Inc.

官方來源

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