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FDA 510(k)

SILVER FOAM WOUND DRESSING

K-Number: K032742 · 2004-08-16

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2004-08-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVER FOAM WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K032742. 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 SILVER FOAM WOUND DRESSING?

SILVER FOAM WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K032742.

When did SILVER FOAM WOUND DRESSING receive FDA 510(k) clearance?

SILVER FOAM WOUND DRESSING received FDA 510(k) clearance on 2004-08-16, under 510(k) number K032742.

Who is the listed applicant for SILVER FOAM WOUND DRESSING?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVER FOAM WOUND DRESSING?

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

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Other records listing Advanced Medical Solutions, Ltd. 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.

K213473Antimicrobial Gelling Fiber Dressing with PHMBK210974High Performance Antimicrobial Gelling Fiber with SilverK190819Silicone PHMB Foam Wound DressingK183645Silver High Performance DressingK180634Surgical Silver Post Operative DressingK181197PHMB Foam Wound Dressing

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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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