The following data is part of a premarket notification filed by Fu Hong Industries Ltd. with the FDA for Fu Hong Industries Limited Soother Teether.
| Device ID | K052531 |
| 510k Number | K052531 |
| Device Name: | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | FU HONG INDUSTRIES LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls FU HONG INDUSTRIES LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-15 |
| Decision Date | 2005-12-14 |