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FDA 510(k)

Silverlon 岛屿伤口敷料，Silverlon 伤口垫敷料（也称为 Silverlon 烧伤垫敷料）

K号: K180570 · 2019-01-14

申请人Argentum Medical, LLC
决定日期2019-01-14
产品代码FRO
决定实质等同

器械摘要

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, LLC. It received FDA 510(k) clearance on 2019-01-14 under 510(k) number K180570. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)?

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is a medical device that received FDA 510(k) clearance on 2019-01-14. The listed applicant is Argentum Medical, LLC. The 510(k) number is K180570.

When did Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) receive FDA 510(k) clearance?

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) received FDA 510(k) clearance on 2019-01-14, under 510(k) number K180570.

Who is the listed applicant for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)?

The FDA 510(k) record lists Argentum Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)?

The FDA product code for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is FRO. This falls under the Anesthesiology category.

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Argentum Medical, LLC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。

K241225Silverlon® 伤口接触，烧伤接触敷料K190343Silverlon 伤口接触，烧伤接触敷料

相关器械（代码：FRO）

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。

K254168Actolind®（06.3637. Actolind®凝胶加强型）ACTO GmbHK254041SkinSmart 抗菌保湿凝胶Magic Science Supply, LLCK261646Redermax® 抗菌伤口基质Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌伤口凝胶Silverceuticals, Inc.K261023Microdacyn 伤口冲洗溶液Sonoma Pharmaceuticals, Inc.

官方来源

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