The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Endoluminal Access Tube.
| Device ID | K941228 |
| 510k Number | K941228 |
| Device Name: | ENDOLUMINAL ACCESS TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-15 |
| Decision Date | 1995-09-27 |