The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Polyurethane Feeding Tube.
| Device ID | K082238 |
| 510k Number | K082238 |
| Device Name: | NEOMED POLYURETHANE FEEDING TUBE |
| Classification | Tube, Feeding |
| Applicant | NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-10-01 |
| Summary: | summary |