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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 the device name listed in this FDA 510(k) record. The listed applicant is Aquilabs Us, LLC. It received FDA 510(k) clearance on 2018-04-13 under 510(k) 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. The listed applicant is Aquilabs Us, LLC. The 510(k) number is K180305.

When did Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) receive FDA 510(k) clearance?

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

Who is the listed applicant for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

The FDA 510(k) record lists Aquilabs Us, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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