510(k) K021193
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2003
- Date Received
- April 15, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractor, Vacuum, Fetal
- Device Class
- Class II
- Regulation Number
- 884.4340
- Review Panel
- OB
- Submission Type