BURNFREE BURNSOOTHE HYDROGEL— 510(k) K943728

Substantially Equivalent for Some Indications

Levtrade Intl. (Pty) , Ltd.

FDA 510(k) clearance K943728 for BURNFREE BURNSOOTHE HYDROGEL, Substantially Equivalent for Some Indications on 1994-09-27. Applicant: Levtrade Intl. (Pty) , Ltd..

Clearance details

Applicant: Levtrade Intl. (Pty) , Ltd.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1994-07-19
Decision date: 1994-09-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Kingham, MA, US

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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.