The following data is part of a premarket notification filed by Royal Industries (thailand) Public Co. Ltd. with the FDA for Water Filled Teether.
| Device ID | K052105 |
| 510k Number | K052105 |
| Device Name: | WATER FILLED TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. 126, MOO 6 SETHAKIT 1, RD., OMNOI, Krathumban, TH 74130 |
| Contact | Andrew Sims |
| Correspondent | Andrew Sims ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. 126, MOO 6 SETHAKIT 1, RD., OMNOI, Krathumban, TH 74130 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-10-31 |