CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES— 510(k) K082910

Substantially Equivalent

Aso, LLC

FDA 510(k) clearance K082910 for CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES, Substantially Equivalent on 2009-06-17. Applicant: Aso, LLC.

Clearance details

Applicant: Aso, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2008-09-30
Decision date: 2009-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.