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FDA 510(k)

PolyPlex Wound Dressing

K-Number: K160872 · 2016-11-23

ApplicantGlobal Health Solutions, LLC
Decision Date2016-11-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PolyPlex Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Global Health Solutions, LLC. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K160872. 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 PolyPlex Wound Dressing?

PolyPlex Wound Dressing is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Global Health Solutions, LLC. The 510(k) number is K160872.

When did PolyPlex Wound Dressing receive FDA 510(k) clearance?

PolyPlex Wound Dressing received FDA 510(k) clearance on 2016-11-23, under 510(k) number K160872.

Who is the listed applicant for PolyPlex Wound Dressing?

The FDA 510(k) record lists Global Health Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PolyPlex Wound Dressing?

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

Other records listing Global Health Solutions, LLC 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.

K171191Hexagen Derm

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.

K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.K254191IWD-Gel™InnovaCorium, Inc.K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation

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.

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