THERMO-PACK— 510(k) K890924

Substantially Equivalent

Medical Manufacturers, Inc.

FDA 510(k) clearance K890924 for THERMO-PACK, Substantially Equivalent on 1989-03-14. Applicant: Medical Manufacturers, Inc..

Clearance details

Applicant: Medical Manufacturers, Inc.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1989-02-24
Decision date: 1989-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.