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510(k) Data Aggregation
K Number
K033164Device Name
ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM
Manufacturer
Date Cleared
2004-09-07
(343 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DR. LEN'S MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is indicated for use for the treatment of pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds (abrasions, lacerations, second degree burns) and draining wounds.
Device Description
The patented Abrams Multi-Density Polyurethane Foam Wound Dressing System is a single-patient use sterile medical device that contains silver based anti-microbial agent, effective as antibacterial barrier in the dressing. The dressing is available in different configurations: 4x4" and 4x8" sizes with adhesive backing, sterile; 4x4" and 4x8" sizes without adhesive backing, sterile; 4x11" size without adhesive backing, sterile, attached to 11x38" cotton bandage.
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