Silverlon Wound Contact, Burn Contact Dressings— 510(k) K190343

Substantially Equivalent

Argentum Medical, LLC

FDA 510(k) clearance K190343 for Silverlon Wound Contact, Burn Contact Dressings, Substantially Equivalent on 2019-07-18. Applicant: Argentum Medical, LLC.

Clearance details

Applicant: Argentum Medical, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2019-02-14
Decision date: 2019-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, IL, 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.