510(k) K791277
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1979
- Date Received
- July 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Cervical, Fixed Size
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type