510(k) K110615
K110615 is an FDA 510(k) premarket notification submitted by Bebe Toys Manufactory , Ltd. for the device "WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE". The FDA issued a decision of Substantially Equivalent on Dec 2, 2011. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 2011
- Date Received
- Mar 3, 2011
- 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
- 510(k) Exempt