The following data is part of a premarket notification filed by Solid Toys Ind. Ltd. with the FDA for Water-filled Teether.
| Device ID | K123855 |
| 510k Number | K123855 |
| Device Name: | WATER-FILLED TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | SOLID TOYS IND. LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SOLID TOYS IND. LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-14 |
| Decision Date | 2013-05-24 |
| Summary: | summary |