Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)— 510(k) K143335

Substantially Equivalent

Roosin Medical Devices Co., Ltd.

FDA 510(k) clearance K143335 for Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC), Substantially Equivalent on 2015-06-01. Applicant: Roosin Medical Devices Co., Ltd..

Clearance details

Applicant: Roosin Medical Devices Co., Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-11-20
Decision date: 2015-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taizhou, CN

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.