510(k) K890388
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1989
- Date Received
- January 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Destructive, Fetal, Obstetric
- Device Class
- Class II
- Regulation Number
- 884.4500
- Review Panel
- OB
- Submission Type