The following data is part of a premarket notification filed by Luv N' Care, Ltd. with the FDA for Gel Filled Gum Soother.
| Device ID | K092494 |
| 510k Number | K092494 |
| Device Name: | GEL FILLED GUM SOOTHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | LUV N' CARE, LTD. 3030 AURORA AVE., 2ND FLOOR Monroe, LA 71201 |
| Contact | Joseph H Hakim |
| Correspondent | Joseph H Hakim LUV N' CARE, LTD. 3030 AURORA AVE., 2ND FLOOR Monroe, LA 71201 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2010-03-01 |