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FDA 510(k)

HYALMIX CREAM

K-Number: K123678 · 2013-12-16

ApplicantIgi Laboratories, Inc.
Decision Date2013-12-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYALMIX CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Igi Laboratories, Inc.. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K123678. 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 HYALMIX CREAM?

HYALMIX CREAM is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Igi Laboratories, Inc.. The 510(k) number is K123678.

When did HYALMIX CREAM receive FDA 510(k) clearance?

HYALMIX CREAM received FDA 510(k) clearance on 2013-12-16, under 510(k) number K123678.

Who is the listed applicant for HYALMIX CREAM?

The FDA 510(k) record lists Igi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYALMIX CREAM?

The FDA product code for HYALMIX CREAM is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Igi Laboratories, Inc. as applicant

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.

K123724DERMISEB CREAM

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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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