Product code OQL
- Device name
- Mesh, Surgical, Deployment Balloon
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
- Source
- FDA openFDA device classification dataset