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FDA 510(k)

SURESKIN SILVER BANDAGES

K-Number: K081274 · 2008-05-28

ApplicantEuromed, Inc.
Decision Date2008-05-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SURESKIN SILVER BANDAGES is the device name listed in this FDA 510(k) record. The listed applicant is Euromed, Inc.. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K081274. 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 SILVER BANDAGES?

SURESKIN SILVER BANDAGES is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Euromed, Inc.. The 510(k) number is K081274.

When did SURESKIN SILVER BANDAGES receive FDA 510(k) clearance?

SURESKIN SILVER BANDAGES received FDA 510(k) clearance on 2008-05-28, under 510(k) number K081274.

Who is the listed applicant for SURESKIN SILVER BANDAGES?

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 SILVER BANDAGES?

The FDA product code for SURESKIN SILVER BANDAGES 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.

K050032EUROMED SURESKIN III WITH SILVER WOUND DRESSINGSK992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINK983249SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS 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.

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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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