RADOVAN SUBCUTANEOUS TISSUE EXPANDER— 510(k) K771224

Substantially Equivalent

Heyer Schulte Corp.

FDA 510(k) clearance K771224 for RADOVAN SUBCUTANEOUS TISSUE EXPANDER, Substantially Equivalent on 1977-10-11. Applicant: Heyer Schulte Corp..

Clearance details

Applicant: Heyer Schulte Corp.
Product code: Code LCJ
Advisory panel: Unknown
Date received: 1977-07-05
Decision date: 1977-10-11
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.