BURN JEL PLUS— 510(k) K003396

Name: FDA 510(k) clearance K003396
Creator: U.S. Food and Drug Administration
Published: 2001-01-11

Substantially Equivalent

Water-Jel Technologies, LLC

FDA 510(k) clearance K003396 for BURN JEL PLUS, Substantially Equivalent on 2001-01-11. Applicant: Water-Jel Technologies, LLC. Device class: Unclassified.

Clearance details

Applicant: Water-Jel Technologies, LLC
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2000-11-01
Decision date: 2001-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlstadt, NJ, US

Download summary PDF View on FDA.gov ↗

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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.