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 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 2017-07-25 under 510(k) 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. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K163062.

When did PHMB Antimicrobial Foam Wound Dressing receive FDA 510(k) clearance?

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

Who is the listed applicant for PHMB Antimicrobial 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 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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.