The following data is part of a premarket notification filed by Medical Infusion Technologies, Inc. with the FDA for Enteral Nutrition 1000 Ml/500ml.
| Device ID | K970849 |
| 510k Number | K970849 |
| Device Name: | ENTERAL NUTRITION 1000 ML/500ML |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDICAL INFUSION TECHNOLOGIES, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Contact | John Mcneirney |
| Correspondent | John Mcneirney MEDICAL INFUSION TECHNOLOGIES, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-08-15 |
| Summary: | summary |