FDA 510(k)

銀隆傷口接觸，燒傷接觸敷料

K 號：K221218 · 2022-10-26

決定日期2022-10-26

產品代碼FRO

決定相當於

器材摘要

Silverlon Wound Contact, Burn Contact Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K221218. 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.

常見問題

What is the Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Argentum Medical, Inc.. The 510(k) number is K221218.

When did Silverlon Wound Contact, Burn Contact Dressings receive FDA 510(k) clearance?

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2022-10-26, under 510(k) number K221218.

Who is the listed applicant for Silverlon Wound Contact, Burn Contact Dressings?

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

What is the FDA product code for Silverlon Wound Contact, Burn Contact Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings is FRO. This falls under the Anesthesiology category.

相關器械（代碼：FRO）

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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FRO）

官方來源