ALBA HEALTH CARE NON-ADHERING DRESSING— 510(k) K850241

Substantially Equivalent

Alba Health Care

FDA 510(k) clearance K850241 for ALBA HEALTH CARE NON-ADHERING DRESSING, Substantially Equivalent on 1985-03-12. Applicant: Alba Health Care.

Clearance details

Applicant: Alba Health Care
Product code: Code FRO
Advisory panel: Unknown
Date received: 1985-01-22
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valdese, NC, 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.