510(k) K092910
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2009
- Date Received
- September 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Teething, Fluid-Filled
- Device Class
- Class II
- Regulation Number
- 872.5550
- Review Panel
- DE
- Submission Type