The following data is part of a premarket notification filed by Bryan Medical , Inc. with the FDA for Tenax Laser Resistant Endotracheal Tube.
| Device ID | K213028 |
| 510k Number | K213028 |
| Device Name: | Tenax Laser Resistant Endotracheal Tube |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Bryan Medical , Inc. 5725 Dragon Way, Suite 300 Cincinnati, OH 45227 |
| Contact | Andrew J Georgilis |
| Correspondent | Martha Kamrow Russell AlvaMed, Inc. 1116 Great Plain Avenue, Suite 1 Needham, MA 02492 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2021-10-21 |