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FDA 510(k)

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)

K-Number: K180305 · 2018-04-13

ApplicantAquilabs Us, LLC
Decision Date2018-04-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is a medical device manufactured by Aquilabs Us, LLC. It received FDA 510(k) clearance on 2018-04-13 under approval number K180305. 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 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Aquilabs Us, LLC. The 510(k) number is K180305.

When was Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) approved by the FDA?

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) received FDA 510(k) clearance on 2018-04-13, under approval number K180305.

What company makes Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is manufactured by Aquilabs Us, LLC.

What is the FDA product code for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

The FDA product code for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is FRO. This falls under the Anesthesiology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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