De Novo DEN090007
- Device
- BIO-SEAL LUNG BIOPSY TRACT SYSTEM
- Contact
- trudy estridge
- De Novo number
- DEN090007
- Product code
- OMT
- Regulation
- 878.4755
- Classification name
- absorbable lung biopsy plug
- Decision
- granted (DENG)
- Decision date
- 2012-12-19
- Date received
- 2009-04-17
- Classification advisory
- General & Plastic Surgery
- Review advisory
- Anesthesiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OMT
- Device name
- Absorbable Lung Biopsy Plug
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4755
- Implant
- Y
- Life sustain/support
- N