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 | K200761 |
| 510k Number | K200761 |
| 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 | Ian Broome AlvaMed, Inc. 1116 Great Plain Avenue, Suite 1 Needham, MA 02492 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-24 |
| Decision Date | 2020-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| TG0070 | K200761 | 000 |
| TG0065 | K200761 | 000 |
| TG0060 | K200761 | 000 |
| TG0055 | K200761 | 000 |
| TG0050 | K200761 | 000 |