BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET— 510(k) K984082

Substantially Equivalent

Emox 911 CC

FDA 510(k) clearance K984082 for BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET, Substantially Equivalent on 1999-01-28. Applicant: Emox 911 CC.

Clearance details

Applicant: Emox 911 CC
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1998-11-16
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset West, ZA

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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.