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FDA 510(k)

SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING

K-Number: K040518 · 2004-10-27

ApplicantSelect Fabricators, Inc.
Decision Date2004-10-27
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Select Fabricators, Inc.. It received FDA 510(k) clearance on 2004-10-27 under 510(k) number K040518. 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 SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING?

SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2004-10-27. The listed applicant is Select Fabricators, Inc.. The 510(k) number is K040518.

When did SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING receive FDA 510(k) clearance?

SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING received FDA 510(k) clearance on 2004-10-27, under 510(k) number K040518.

Who is the listed applicant for SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING?

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

What is the FDA product code for SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING?

The FDA product code for SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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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

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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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