Product code PQN
- Device name
- Carbon Dioxide Gas Controlled Tissue Expander
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3510
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
- Source
- FDA openFDA device classification dataset