SILVERLEAF CONTACT WOUND DRESSING— 510(k) K013936

Substantially Equivalent

Silverleaf Technologies, Inc.

FDA 510(k) clearance K013936 for SILVERLEAF CONTACT WOUND DRESSING, Substantially Equivalent on 2003-03-18. Applicant: Silverleaf Technologies, Inc..

Clearance details

Applicant: Silverleaf Technologies, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2001-11-28
Decision date: 2003-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, Ontario, 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.