The following data is part of a premarket notification filed by Spiway, Llc with the FDA for Spiway Endonasal Access Guide.
Device ID | K213153 |
510k Number | K213153 |
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 | 2021-09-28 |
Decision Date | 2021-10-27 |