3M TEGADERM CHG DRESSING— 510(k) K063458

Substantially Equivalent

3M Company

FDA 510(k) clearance K063458 for 3M TEGADERM CHG DRESSING, Substantially Equivalent on 2007-04-05. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code FRO
Advisory panel: Unknown
Date received: 2006-11-15
Decision date: 2007-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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.