# Kolplast Comercial E Industrial Ltda

- Location (FDA's records): Crofton, MD
- FDA decisions: 1 (1997–1997): 1 510(k) clearance
- Product codes: HIB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K973853: Kolplast Vaginal Speculum (Dec 19, 1997)

Source page: https://510kreport.com/company/kolplast-comercial-e-industrial