Antibacterial Bandage
K-Number: K201324 · 2021-02-05
Decision Date2021-02-05
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Antibacterial Bandage is a medical device manufactured by Jiangsu Excellence Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-02-05 under approval number K201324. 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.
Frequently Asked Questions
What is the Antibacterial Bandage?
Antibacterial Bandage is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Jiangsu Excellence Medical Supplies Co., Ltd.. The 510(k) number is K201324.
When was Antibacterial Bandage approved by the FDA?
Antibacterial Bandage received FDA 510(k) clearance on 2021-02-05, under approval number K201324.
What company makes Antibacterial Bandage?
Antibacterial Bandage is manufactured by Jiangsu Excellence Medical Supplies Co., Ltd..
What is the FDA product code for Antibacterial Bandage?
The FDA product code for Antibacterial Bandage is FRO. This falls under the Anesthesiology category.
Other Devices by Jiangsu Excellence Medical Supplies Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.