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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K180141
Device Name SPIWay Endonasal Access Guide
Applicant
SPIWay, LLC
3600 Corte Castillo
Carlsbad,  CA  92009
Applicant Contact Eugene Chen
Correspondent
SPIWay, LLC
3600 Corte Castillo
Carlsbad,  CA  92009
Correspondent Contact Mary Lou Mooney
Regulation Number874.4780
Classification Product Code
LYA  
Date Received01/18/2018
Decision Date 02/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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