The following data is part of a premarket notification filed by Royal King Infant Products Co. Ltd. with the FDA for Fluid Filled Teethers.
| Device ID | K031094 |
| 510k Number | K031094 |
| Device Name: | FLUID FILLED TEETHERS |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | ROYAL KING INFANT PRODUCTS CO. LTD. 73/4 M00 1 KHAELIE Krathumbaen, Samutsakor, TH 74110 |
| Contact | Dalbir Singh Khurana |
| Correspondent | Dalbir Singh Khurana ROYAL KING INFANT PRODUCTS CO. LTD. 73/4 M00 1 KHAELIE Krathumbaen, Samutsakor, TH 74110 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-12-08 |