The following data is part of a premarket notification filed by Footprint Medical Inc. with the FDA for Footprint Medical Polyurethane Feeding Tube.
| Device ID | K102548 |
| 510k Number | K102548 |
| Device Name: | FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | FOOTPRINT MEDICAL INC. 1203 CAMDEN STREET San Antonio, TX 78215 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker FOOTPRINT MEDICAL INC. 1203 CAMDEN STREET San Antonio, TX 78215 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2010-11-26 |