The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Micro Transgastric-jejunal Feeding Device.
| Device ID | K183508 |
| 510k Number | K183508 |
| Device Name: | Micro Transgastric-Jejunal Feeding Device |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 |
| Contact | Joy Tubero |
| Correspondent | Joy Tubero Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-03-29 |