HONEY ALGINATE DRESSING— 510(k) K053095

Substantially Equivalent

Derma Sciences Canada, Inc.

FDA 510(k) clearance K053095 for HONEY ALGINATE DRESSING, Substantially Equivalent on 2007-07-12. Applicant: Derma Sciences Canada, Inc..

Clearance details

Applicant: Derma Sciences Canada, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2005-11-03
Decision date: 2007-07-12
Decision: Substantially Equivalent
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.