Product code PKN
- Device name
- Dilator, Cervical, Synthetic, Osmotic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4260
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Cervical softening and dilation
- Source
- FDA openFDA device classification dataset