510(k) K092025
K092025 is an FDA 510(k) premarket notification submitted by Kids II for the device "FLUID FILLED TEETHER - GEL". The FDA issued a decision of Substantially Equivalent on Jan 27, 2011. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Kids II has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 27, 2011
- Date Received
- Jul 6, 2009
- Clearance Type
- Abbreviated
- 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
- 510(k) Exempt