510(k) K060363— HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12

Substantially Equivalent

Hemcon, Inc.

Clearance details

Applicant: Hemcon, Inc.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2006-02-13
Decision date: 2006-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.