FDA 510(k)

銀藻鹼鹼敷料（處方藥使用），抗細菌鹼鹼繩帶敷料（非處方藥使用）

K 號：K202982 · 2021-10-19

決定日期2021-10-19

產品代碼FRO

決定相當於

器材摘要

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K202982. 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 Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)?

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K202982.

When did Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) receive FDA 510(k) clearance?

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) received FDA 510(k) clearance on 2021-10-19, under 510(k) number K202982.

Who is the listed applicant for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)?

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

What is the FDA product code for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)?

The FDA product code for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) is FRO. This falls under the Anesthesiology category.