DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL— 510(k) K980861

Substantially Equivalent

Dumex Medical Surgical Products, Ltd.

FDA 510(k) clearance K980861 for DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL, Substantially Equivalent on 1998-05-20. Applicant: Dumex Medical Surgical Products, Ltd..

Clearance details

Applicant: Dumex Medical Surgical Products, Ltd.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1998-03-05
Decision date: 1998-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Orntario, CA

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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.