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FDA 510(k)

IODOFOAM IODOPHOR FOAM DRESSING

K-Number: K122634 · 2013-03-12

ApplicantProgressive Wound Care Technologies, LLC
Decision Date2013-03-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

IODOFOAM IODOPHOR FOAM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Wound Care Technologies, LLC. It received FDA 510(k) clearance on 2013-03-12 under 510(k) number K122634. 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 IODOFOAM IODOPHOR FOAM DRESSING?

IODOFOAM IODOPHOR FOAM DRESSING is a medical device that received FDA 510(k) clearance on 2013-03-12. The listed applicant is Progressive Wound Care Technologies, LLC. The 510(k) number is K122634.

When did IODOFOAM IODOPHOR FOAM DRESSING receive FDA 510(k) clearance?

IODOFOAM IODOPHOR FOAM DRESSING received FDA 510(k) clearance on 2013-03-12, under 510(k) number K122634.

Who is the listed applicant for IODOFOAM IODOPHOR FOAM DRESSING?

The FDA 510(k) record lists Progressive Wound Care Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IODOFOAM IODOPHOR FOAM DRESSING?

The FDA product code for IODOFOAM IODOPHOR FOAM DRESSING is FRO. This falls under the Anesthesiology category.

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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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