The following data is part of a premarket notification filed by Allied Hill Enterprises, Ltd. with the FDA for Liquid Filled Ring Teether, Model 03807, Liquid Filled Ring Teether, Models 1962005, 1962011, Liquid Filled Teething.
| Device ID | K091198 |
| 510k Number | K091198 |
| Device Name: | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | ALLIED HILL ENTERPRISES, LTD. 34 MCNAMARA STREET Stoughton, MA 02072 |
| Contact | Paul A Ware |
| Correspondent | Paul A Ware ALLIED HILL ENTERPRISES, LTD. 34 MCNAMARA STREET Stoughton, MA 02072 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-24 |
| Decision Date | 2009-12-07 |