VAN-TEC FASCIAL DILATOR— 510(k) K820865

Substantially Equivalent

Van-Tec, Inc.

FDA 510(k) clearance K820865 for VAN-TEC FASCIAL DILATOR, Substantially Equivalent on 1982-05-05. Applicant: Van-Tec, Inc..

Clearance details

Applicant: Van-Tec, Inc.
Product code: Code GCC
Advisory panel: General, Plastic Surgery
Date received: 1982-03-29
Decision date: 1982-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code GCC

product code GCC

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.