DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)— 510(k) K080497

Substantially Equivalent

Derma Sciences Canada, Inc.

FDA 510(k) clearance K080497 for DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG), Substantially Equivalent on 2008-06-27. Applicant: Derma Sciences Canada, Inc..

Clearance details

Applicant: Derma Sciences Canada, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2008-02-22
Decision date: 2008-06-27
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.