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FDA 510(k)

ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM

K-Number: K033164 · 2004-09-07

ApplicantDr. Len'S Medical Products, LLC
Decision Date2004-09-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Len'S Medical Products, LLC. It received FDA 510(k) clearance on 2004-09-07 under 510(k) number K033164. 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 ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM?

ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-07. The listed applicant is Dr. Len'S Medical Products, LLC. The 510(k) number is K033164.

When did ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM receive FDA 510(k) clearance?

ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM received FDA 510(k) clearance on 2004-09-07, under 510(k) number K033164.

Who is the listed applicant for ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM?

The FDA 510(k) record lists Dr. Len'S Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM?

The FDA product code for ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM 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.

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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