KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)— 510(k) K970399

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K970399 for KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD), Substantially Equivalent on 1997-04-03. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.