The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Traditional Length Gj Feeding Device.
| Device ID | K182804 |
| 510k Number | K182804 |
| Device Name: | Traditional Length GJ 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-02 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071125516 | K182804 | 000 |
| 00842071125288 | K182804 | 000 |
| 00842071125264 | K182804 | 000 |
| 00842071125240 | K182804 | 000 |
| 00842071125233 | K182804 | 000 |
| 00842071125226 | K182804 | 000 |
| 00842071125219 | K182804 | 000 |
| 00842071125196 | K182804 | 000 |
| 00842071125189 | K182804 | 000 |
| 00842071125172 | K182804 | 000 |
| 00842071125363 | K182804 | 000 |
| 00842071125295 | K182804 | 000 |
| 00842071125318 | K182804 | 000 |
| 00842071125493 | K182804 | 000 |
| 00842071125486 | K182804 | 000 |
| 00842071125462 | K182804 | 000 |
| 00842071125448 | K182804 | 000 |
| 00842071125431 | K182804 | 000 |
| 00842071125424 | K182804 | 000 |
| 00842071125417 | K182804 | 000 |
| 00842071125394 | K182804 | 000 |
| 00842071125387 | K182804 | 000 |
| 00842071125370 | K182804 | 000 |
| 00842071125349 | K182804 | 000 |