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FDA 510(k)

SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN

K-Number: K983249 · 1998-11-25

ApplicantEuromed, Inc.
Decision Date1998-11-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN is the device name listed in this FDA 510(k) record. The listed applicant is Euromed, Inc.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983249. 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 SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN?

SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Euromed, Inc.. The 510(k) number is K983249.

When did SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN receive FDA 510(k) clearance?

SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983249.

Who is the listed applicant for SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN?

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

What is the FDA product code for SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN?

The FDA product code for SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Euromed, Inc. 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.

K081274SURESKIN SILVER BANDAGESK050032EUROMED SURESKIN III WITH SILVER WOUND DRESSINGSK992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN

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

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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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