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FDA 510(k)

PHMB Antimicrobial Foam Wound Dressing

K-Number: K163062 · 2017-07-25

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2017-07-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PHMB Antimicrobial Foam Wound Dressing is a medical device manufactured by Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2017-07-25 under approval number K163062. 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 PHMB Antimicrobial Foam Wound Dressing?

PHMB Antimicrobial Foam Wound Dressing is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by Advanced Medical Solutions, Ltd.. The 510(k) number is K163062.

When was PHMB Antimicrobial Foam Wound Dressing approved by the FDA?

PHMB Antimicrobial Foam Wound Dressing received FDA 510(k) clearance on 2017-07-25, under approval number K163062.

What company makes PHMB Antimicrobial Foam Wound Dressing?

PHMB Antimicrobial Foam Wound Dressing is manufactured by Advanced Medical Solutions, Ltd..

What is the FDA product code for PHMB Antimicrobial Foam Wound Dressing?

The FDA product code for PHMB Antimicrobial Foam Wound Dressing is FRO. This falls under the Anesthesiology category.

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Other Devices by Advanced Medical Solutions, Ltd.

K180634Surgical Silver Post Operative Dressing K181197PHMB Foam Wound Dressing K190819Silicone PHMB Foam Wound Dressing K183645Silver High Performance Dressing K210974High Performance Antimicrobial Gelling Fiber with Silver K213473Antimicrobial Gelling Fiber Dressing with PHMB

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Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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