The following data is part of a premarket notification filed by Wiltec Industries Ltd. with the FDA for Fluid-filled Teether.
| Device ID | K083512 |
| 510k Number | K083512 |
| Device Name: | FLUID-FILLED TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | WILTEC INDUSTRIES LTD. 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls WILTEC INDUSTRIES LTD. 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-04-22 |