DUMEX WET DRESSINGS— 510(k) K950132

Substantially Equivalent for Some Indications

Dumex Medical Surgical Products, Ltd.

FDA 510(k) clearance K950132 for DUMEX WET DRESSINGS, Substantially Equivalent for Some Indications on 1995-03-01. Applicant: Dumex Medical Surgical Products, Ltd..

Clearance details

Applicant: Dumex Medical Surgical Products, Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1995-01-13
Decision date: 1995-03-01
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.