The following data is part of a premarket notification filed by Spiway Llc with the FDA for Spiway Endonasal Access Guide.
| Device ID | K153686 |
| 510k Number | K153686 |
| Device Name: | SPIWay Endonasal Access Guide |
| Classification | Splint, Intranasal Septal |
| Applicant | SPIWAY LLC 1120 CALLE CORDILLERA, #102 San Clemente, CA 92673 |
| Contact | Eugene Chen |
| Correspondent | Mary Lou Mooney SPIWAY LLC 1120 CALLE CORDILLERA, #102 San Clemente, CA 92673 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-01-28 |