The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Infant Feeding Tubes.
| Device ID | K020005 |
| 510k Number | K020005 |
| Device Name: | INFANT FEEDING TUBES |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-02 |
| Decision Date | 2002-07-16 |
| Summary: | summary |