KOLD WRAP STERILE BURN DRESSING— 510(k) K920554

Substantially Equivalent

Kold Products

FDA 510(k) clearance K920554 for KOLD WRAP STERILE BURN DRESSING, Substantially Equivalent on 1993-02-19. Applicant: Kold Products.

Clearance details

Applicant: Kold Products
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1992-02-06
Decision date: 1993-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.