The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Low-profile Transgastric-jejunal Feeding Tube Kit.
| Device ID | K123716 |
| 510k Number | K123716 |
| Device Name: | AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Grant W Phillips |
| Correspondent | Grant W Phillips APPLIED MEDICAL TECHNOLOGY, INC. 8000 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 | 2012-12-04 |
| Decision Date | 2013-04-19 |