FDA 510(k)

樓福康矽膠泡沫敷料，帶邊緣

K 號：K170077 · 2017-03-30

申請人Huizhou Foryou Medical Devices Co., Ltd.

決定日期2017-03-30

產品代碼FRO

決定相當於

器材摘要

LUOFUCON Silicone Ag Foam Dressing with Border is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-03-30 under 510(k) number K170077. 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 LUOFUCON Silicone Ag Foam Dressing with Border?

LUOFUCON Silicone Ag Foam Dressing with Border is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K170077.

When did LUOFUCON Silicone Ag Foam Dressing with Border receive FDA 510(k) clearance?

LUOFUCON Silicone Ag Foam Dressing with Border received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170077.

Who is the listed applicant for LUOFUCON Silicone Ag Foam Dressing with Border?

FDA 510(k) 記錄將惠州富友醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for LUOFUCON Silicone Ag Foam Dressing with Border?

The FDA product code for LUOFUCON Silicone Ag Foam Dressing with Border is FRO. This falls under the Anesthesiology category.

其他以 Huizhou Foryou Medical Devices Co., Ltd. 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。

K254256LOUFUCON® 黃金創傷組織 K250642LOUFOCON®皮膚及傷口清潔劑（噴霧、霧狀、壓嘴、瓶裝。）K240809LOUFOCON® 銀膠原蛋白敷料 K242856LUOFUCON®矽膠Ag+泡沫敷料（處方用）/ LUOFUCON®矽膠Ag+抗菌泡沫敷料（OTC用）(邊框型、邊框輕型、無邊框型和轉移型)K240485LUOFUCON® 銀膠凝纖維敷料（處方用），LUOFUCON® 銀抗菌膠凝纖維敷料（OTC用）K232796LOUFOCON® 膠原蛋白粒子（膠原蛋白傷口敷料）

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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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