K970399

Substantially Equivalent

KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)

Applicant: Allegiance Healthcare Corp.
Product code: IMD
Advisory panel: Physical Medicine
Date received: 1997-02-03
Decision date: 1997-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.