510(k) K130259
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2013
- Date Received
- February 1, 2013
- 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