ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM— 510(k) K033164

Substantially Equivalent

Dr. Len'S Medical Products, LLC

FDA 510(k) clearance K033164 for ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM, Substantially Equivalent on 2004-09-07. Applicant: Dr. Len'S Medical Products, LLC.

Clearance details

Applicant: Dr. Len'S Medical Products, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2003-09-30
Decision date: 2004-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.