The following data is part of a premarket notification filed by Global Treasure Industries Ltd. with the FDA for Global Treasures Fluid Filled Teether.
| Device ID | K043033 |
| 510k Number | K043033 |
| Device Name: | GLOBAL TREASURES FLUID FILLED TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | GLOBAL TREASURE INDUSTRIES LTD. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White GLOBAL TREASURE INDUSTRIES LTD. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2005-03-22 |
| Summary: | summary |