510(k) K014023
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2002
- Date Received
- December 6, 2001
- 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