anti-bacterial bandage
K-Number: K200821 · 2020-10-19
Decision Date2020-10-19
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
anti-bacterial bandage is a medical device manufactured by Planet (Suzhou) Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under approval number K200821. 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 anti-bacterial bandage?
anti-bacterial bandage is a medical device that received FDA 510(k) clearance on 2020-10-19. It is manufactured by Planet (Suzhou) Medical Products Co., Ltd.. The 510(k) number is K200821.
When was anti-bacterial bandage approved by the FDA?
anti-bacterial bandage received FDA 510(k) clearance on 2020-10-19, under approval number K200821.
What company makes anti-bacterial bandage?
anti-bacterial bandage is manufactured by Planet (Suzhou) Medical Products Co., Ltd..
What is the FDA product code for anti-bacterial bandage?
The FDA product code for anti-bacterial bandage is FRO. This falls under the Anesthesiology category.
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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.