# Dilator, Cervical, Expandable
> **Product code: HDN** · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.4250
## Classification
- **FDA Product Code:** HDN
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 884.4250
- **Review panel:** OB
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=HDN)
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