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FDA 510(k)

HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER

K-Number: K061227 · 2006-12-20

ApplicantThe Hymed Group Corp.
Decision Date2006-12-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER is the device name listed in this FDA 510(k) record. The listed applicant is The Hymed Group Corp.. It received FDA 510(k) clearance on 2006-12-20 under 510(k) number K061227. 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 HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER?

HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER is a medical device that received FDA 510(k) clearance on 2006-12-20. The listed applicant is The Hymed Group Corp.. The 510(k) number is K061227.

When did HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER receive FDA 510(k) clearance?

HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER received FDA 510(k) clearance on 2006-12-20, under 510(k) number K061227.

Who is the listed applicant for HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER?

The FDA 510(k) record lists The Hymed Group Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER?

The FDA product code for HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing The Hymed Group Corp. 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.

K994339HYCURE ORAL / HYCURE ORAL SMART GELK961930CHONDROPROTECK960686HYCOATK955506HYCURE

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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