The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Bridle - Nasal Tube Retention System.
| Device ID | K142971 |
| 510k Number | K142971 |
| Device Name: | AMT Bridle - Nasal Tube Retention System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Applied Medical Technology, Inc. 8000 Katherine Blvd. Brecksville, OH 44141 |
| Contact | Joshua Meinke |
| Correspondent | Joshua Meinke Applied Medical Technology, Inc. 8000 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 | 2014-10-14 |
| Decision Date | 2015-05-26 |
| Summary: | summary |