De Novo DEN240075
- Device
- Prolystica Pass Thru Disinfectant Wipes
- Contact
- steve elliott
- De Novo number
- DEN240075
- Product code
- SHM
- Regulation
- 880.6891
- Classification name
- interim reprocessing cleaning and intermediate-level disinfection wipe
- Decision
- granted (DENG)
- Decision date
- 2026-05-01
- Date received
- 2024-12-12
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct