510(k) K030966
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2003
- Date Received
- March 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agents, Embolic, For Treatment Of Uterine Fibroids
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- OB
- Submission Type