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FDA 510(k)

SURESKIN STANDARD, BORDER, AND THIN

K-Number: K963039 · 1996-09-23

ApplicantEuromed A/S
Decision Date1996-09-23
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

SURESKIN STANDARD, BORDER, AND THIN is the device name listed in this FDA 510(k) record. The listed applicant is Euromed A/S. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K963039. 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 for Some Indications.

Frequently Asked Questions

What is the SURESKIN STANDARD, BORDER, AND THIN?

SURESKIN STANDARD, BORDER, AND THIN is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Euromed A/S. The 510(k) number is K963039.

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

SURESKIN STANDARD, BORDER, AND THIN received FDA 510(k) clearance on 1996-09-23, under 510(k) number K963039.

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

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

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

The FDA product code for SURESKIN STANDARD, BORDER, AND 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 A/S 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.

K960394SURESKIN STANDARDK960393SURESKIN BORDERK960404SURESKIN 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

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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