The following data is part of a premarket notification filed by Securisyn Medical, Llc with the FDA for Solidairity Iii Airway Stabilization System.
| Device ID | K190630 |
| 510k Number | K190630 |
| Device Name: | SolidAIRity III Airway Stabilization System |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Securisyn Medical, LLC 9150 Commerce Center Circle, Suite 135 Highlands Ranch, CO 80129 |
| Contact | Arthur Kanowitz |
| Correspondent | Arthur Kanowitz Securisyn Medical, LLC 9150 Commerce Center Circle, Suite 135 Highlands Ranch, CO 80129 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-12 |
| Decision Date | 2019-10-09 |
| Summary: | summary |