The following data is part of a premarket notification filed by Bebe Toys Manufactory Ltd. with the FDA for Water Filled Teether, Water Filled Teether With Handle.
| Device ID | K110615 |
| 510k Number | K110615 |
| Device Name: | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | BEBE TOYS MANUFACTORY LTD. 34 MCNAMARA STREET Stoughton, MA 02072 |
| Contact | Paul A Ware |
| Correspondent | Paul A Ware BEBE TOYS MANUFACTORY LTD. 34 MCNAMARA STREET Stoughton, MA 02072 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-12-02 |