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FDA 510(k)

Gold 锥形重睑植入物，铂金锥形重睑植入物

K号: K203569 · 2021-06-11

申请人Fci (France Chirurgie Instrumentation) Sas
决定日期2021-06-11
产品代码NCB
咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants 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 2021-06-11 under 510(k) number K203569. The device is classified under product code NCB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants?

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K203569.

When did Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants receive FDA 510(k) clearance?

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants received FDA 510(k) clearance on 2021-06-11, under 510(k) number K203569.

Who is the listed applicant for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants?

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 Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants?

The FDA product code for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants is NCB.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K212741EZYPORK201892Ritleng®+ 和 Ritleng®+ PVPK201606LacriJet®

官方来源

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