KERATEC WOUND DRESSINGS— 510(k) K080949

Substantially Equivalent

Keratec Limited

FDA 510(k) clearance K080949 for KERATEC WOUND DRESSINGS, Substantially Equivalent on 2009-02-11. Applicant: Keratec Limited.

Clearance details

Applicant: Keratec Limited
Product code: Code FRO
Advisory panel: Unknown
Date received: 2008-04-03
Decision date: 2009-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.