SPIWay Endonasal Access Guide

Splint, Intranasal Septal

SPIWay, LLC

The following data is part of a premarket notification filed by Spiway, Llc with the FDA for Spiway Endonasal Access Guide.

Pre-market Notification Details

Device IDK213153
510k NumberK213153
Device Name:SPIWay Endonasal Access Guide
ClassificationSplint, Intranasal Septal
Applicant SPIWay, LLC 3600 Corte Castillo Carlsbad,  CA  92009
ContactEugene Chen
CorrespondentMary Lou Mooney
SPIWay, LLC 3600 Corte Castillo Carlsbad,  CA  92009
Product CodeLYA  
CFR Regulation Number874.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-28
Decision Date2021-10-27

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