The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Low Profile Balloon Feeding Device.
| Device ID | K161413 |
| 510k Number | K161413 |
| Device Name: | Low Profile Balloon Feeding Device |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8006 KATHERINE BLVD Brecksville, OH 44141 |
| Contact | Michelle Scott |
| Correspondent | Michelle Scott APPLIED MEDICAL TECHNOLOGY, INC. 8006 KATHERINE BLVD 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 | 2016-05-23 |
| Decision Date | 2017-02-09 |
| Summary: | summary |