FDA 510(k)

樓福康銀膠纖維外科敷料，樓福康抗菌膠纖維覆蓋敷料

K 號：K221110 · 2024-01-04

申請人Huizhou Foryou Medical Devices Co., Ltd.

決定日期2024-01-04

產品代碼FRO

決定相當於

器材摘要

LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing 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 2024-01-04 under 510(k) number K221110. 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 Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing?

LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K221110.

When did LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing receive FDA 510(k) clearance?

LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing received FDA 510(k) clearance on 2024-01-04, under 510(k) number K221110.

Who is the listed applicant for LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing?

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 Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing?

The FDA product code for LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing is FRO. This falls under the Anesthesiology category.