CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266— 510(k) K090026

Substantially Equivalent

Hem Con Medical Technologies, Inc.

FDA 510(k) clearance K090026 for CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266, Substantially Equivalent on 2009-03-31. Applicant: Hem Con Medical Technologies, Inc..

Clearance details

Applicant: Hem Con Medical Technologies, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2009-01-05
Decision date: 2009-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.