SOFTSEAL-STF— 510(k) K090100

Name: FDA 510(k) clearance K090100
Creator: U.S. Food and Drug Administration
Published: 2009-03-11

Substantially Equivalent

Chitogen, Inc.

FDA 510(k) clearance K090100 for SOFTSEAL-STF, Substantially Equivalent on 2009-03-11. Applicant: Chitogen, Inc.. Device class: Unclassified.

Clearance details

Applicant: Chitogen, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2009-01-15
Decision date: 2009-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.