KALTOSTAT WOUND DRESSING— 510(k) K910059

Substantially Equivalent

Calgon Vestal Div.

FDA 510(k) clearance K910059 for KALTOSTAT WOUND DRESSING, Substantially Equivalent on 1991-03-20. Applicant: Calgon Vestal Div..

Clearance details

Applicant: Calgon Vestal Div.
Product code: Code QSY
Advisory panel: Unknown
Date received: 1991-01-09
Decision date: 1991-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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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.