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FDA 510(k)

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND

K-Number: K091013 · 2009-07-30

ApplicantAdvanced Medical Solutions Limited
Decision Date2009-07-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions Limited. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K091013. 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 PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND?

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Advanced Medical Solutions Limited. The 510(k) number is K091013.

When did SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND receive FDA 510(k) clearance?

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND received FDA 510(k) clearance on 2009-07-30, under 510(k) number K091013.

Who is the listed applicant for SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND?

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

What is the FDA product code for SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND?

The FDA product code for SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND is FRO. This falls under the Anesthesiology category.

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Other records listing Advanced Medical Solutions Limited as applicant

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K223310Antimicrobial Silicone PHMB Foam Wound DressingK211878LiquiBand XLK183570LiquiBand PlusK110458SILVER ANTIMICROBIAL WOUND GELK090453SILVER ALGINATE 11 WOUND DRESSINGK080503SILVER ALGINATE IV ANTIMICROBIAL 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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