The following data is part of a premarket notification filed by Spiway, Llc with the FDA for Spiway Endonasal Access Guide.
| Device ID | K180141 |
| 510k Number | K180141 |
| Device Name: | SPIWay Endonasal Access Guide |
| Classification | Splint, Intranasal Septal |
| Applicant | SPIWay, LLC 3600 Corte Castillo Carlsbad, CA 92009 |
| Contact | Eugene Chen |
| Correspondent | Mary Lou Mooney SPIWay, LLC 3600 Corte Castillo Carlsbad, CA 92009 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-18 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003136416 | K180141 | 000 |
| 00860003136409 | K180141 | 000 |