RADOVAN SUBCUTANEOUS TISSUE EXPANDER— 510(k) K833502

Substantially Equivalent

American Heyer Schulte

FDA 510(k) clearance K833502 for RADOVAN SUBCUTANEOUS TISSUE EXPANDER, Substantially Equivalent on 1984-02-03. Applicant: American Heyer Schulte.

Clearance details

Applicant: American Heyer Schulte
Product code: Code LCJ
Advisory panel: Unknown
Date received: 1983-10-05
Decision date: 1984-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

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.