INSTANT ICE PACK— 510(k) K901834

Substantially Equivalent

Impact Packaging Corp.

FDA 510(k) clearance K901834 for INSTANT ICE PACK, Substantially Equivalent on 1990-05-03. Applicant: Impact Packaging Corp..

Clearance details

Applicant: Impact Packaging Corp.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1990-04-24
Decision date: 1990-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, 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.