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 | K093370 |
| 510k Number | K093370 |
| Device Name: | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | FU HONG INDUSTRIES LTD. 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Contact | Kevin Walls, Rac |
| Correspondent | Kevin Walls, Rac FU HONG 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 | 2009-10-29 |
| Decision Date | 2010-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00715418095172 | K093370 | 000 |
| 30715418091144 | K093370 | 000 |
| 30715418091137 | K093370 | 000 |
| 30715418028591 | K093370 | 000 |
| 30715418020359 | K093370 | 000 |