DUMEX IODOFORM PACKING STRIP— 510(k) K990332

Substantially Equivalent for Some Indications

Dumex Medical Surgical Products, Ltd.

FDA 510(k) clearance K990332 for DUMEX IODOFORM PACKING STRIP, Substantially Equivalent for Some Indications on 1999-04-14. Applicant: Dumex Medical Surgical Products, Ltd..

Clearance details

Applicant: Dumex Medical Surgical Products, Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1999-02-03
Decision date: 1999-04-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Toronto, Orntario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.