The following data is part of a premarket notification filed by Applied Medical Technology Inc. with the FDA for Low Profile Non-balloon Feeding Device.
| Device ID | K170319 |
| 510k Number | K170319 |
| Device Name: | Low Profile Non-Balloon Feeding Device |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGY INC. 8006 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Shraddha Saini |
| Correspondent | Shraddha Saini 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 | 2017-02-01 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071132156 | K170319 | 000 |
| 00842071132057 | K170319 | 000 |
| 00842071132064 | K170319 | 000 |
| 00842071132071 | K170319 | 000 |
| 00842071132088 | K170319 | 000 |
| 00842071132095 | K170319 | 000 |
| 00842071132101 | K170319 | 000 |
| 00842071132118 | K170319 | 000 |
| 00842071132125 | K170319 | 000 |
| 00842071132132 | K170319 | 000 |
| 00842071132149 | K170319 | 000 |
| 00842071132040 | K170319 | 000 |