De Novo DEN980001
- Device
- DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND
- Contact
- timothy r littlefield
- De Novo number
- DEN980001
- Product code
- MVA
- Regulation
- 882.5970
- Classification name
- orthosis, cranial
- Decision
- granted (DENG)
- Decision date
- 1998-05-29
- Date received
- 1998-03-31
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- MVA
- Device name
- Orthosis, Cranial
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5970
- Implant
- N
- Life sustain/support
- N