# LEM: Human Lyophilized Dura Mater

- Device class: 2; regulation: 21 CFR 882.5975; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1992: 2

## Most-cited predicates
- K910555: Tutoplast Dura (1992), cited by 2

Source page: https://510kreport.com/product-code/LEM
Data by year (CSV): https://510kreport.com/product-code/LEM.csv