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FDA 510(k)

Algidex Ag Silver Alginate Wound Dressing

K-Number: K173072 · 2018-04-04

ApplicantDeroyal Industries, Inc.
Decision Date2018-04-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Algidex Ag Silver Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K173072. 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 Algidex Ag Silver Alginate Wound Dressing?

Algidex Ag Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K173072.

When did Algidex Ag Silver Alginate Wound Dressing receive FDA 510(k) clearance?

Algidex Ag Silver Alginate Wound Dressing received FDA 510(k) clearance on 2018-04-04, under 510(k) number K173072.

Who is the listed applicant for Algidex Ag Silver Alginate Wound Dressing?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Algidex Ag Silver Alginate Wound Dressing?

The FDA product code for Algidex Ag Silver Alginate Wound Dressing is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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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