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FDA 510(k)

Skin and Wound Cleanser

K-Number: K231564 · 2023-11-10

ApplicantWinner Medical Co., Ltd.
Decision Date2023-11-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Skin and Wound Cleanser is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-11-10 under approval number K231564. 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 Skin and Wound Cleanser?

Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2023-11-10. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K231564.

When was Skin and Wound Cleanser approved by the FDA?

Skin and Wound Cleanser received FDA 510(k) clearance on 2023-11-10, under approval number K231564.

What company makes Skin and Wound Cleanser?

Skin and Wound Cleanser is manufactured by Winner Medical Co., Ltd..

What is the FDA product code for Skin and Wound Cleanser?

The FDA product code for Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

Other Devices by Winner Medical Co., Ltd.

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Related Devices (Code: FRO)

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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.

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