FDA 510(k)

银藻酸盐敷料（处方使用），抗菌藻酸盐敷料（非处方使用）

K号: K202982 · 2021-10-19

决定日期2021-10-19

产品代码FRO

决定实质等同

器械摘要

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.

常见问题

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.

列明Winner Medical Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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