The following data is part of a premarket notification filed by Kids Ii with the FDA for Fluid Filled Teether - Gel.
| Device ID | K092025 |
| 510k Number | K092025 |
| Device Name: | FLUID FILLED TEETHER - GEL |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | KIDS II 555 NORTH POINT CENTER SUITE 600 Alpharetta, GA 30022 |
| Contact | Bob Coughlin |
| Correspondent | Bob Coughlin KIDS II 555 NORTH POINT CENTER SUITE 600 Alpharetta, GA 30022 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2011-01-27 |