The following data is part of a premarket notification filed by Spiway Llc with the FDA for Spiway Endonasal Access Guide.
| Device ID | K132721 |
| 510k Number | K132721 |
| Device Name: | SPIWAY ENDONASAL ACCESS GUIDE |
| Classification | Splint, Intranasal Septal |
| Applicant | SPIWAY LLC 1046 LA MIRADA ST. Laguna Beach, CA 92651 |
| Contact | Mary Lou Mooney |
| Correspondent | Mary Lou Mooney SPIWAY LLC 1046 LA MIRADA ST. Laguna Beach, CA 92651 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-30 |
| Decision Date | 2014-01-29 |
| Summary: | summary |