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FDA 510(k)

銀隆島傷口敷料，銀隆傷口敷料墊（亦稱為銀隆燒傷敷料墊）

K 號：K180570 · 2019-01-14

申請人Argentum Medical, LLC
決定日期2019-01-14
產品代碼FRO
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Argentum Medical, LLC 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。

K241225銀隆® 创面接觸，燒傷接觸敷料K190343銀隆傷口接觸，燒傷接觸敷料

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。

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官方來源

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