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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 K132721
Device Name SPIWAY ENDONASAL ACCESS GUIDE
Applicant
SPIWAY LLC
1046 LA MIRADA ST.
LAGUNA BEACH,  CA  92651
Applicant Contact MARY LOU MOONEY
Correspondent
SPIWAY LLC
1046 LA MIRADA ST.
LAGUNA BEACH,  CA  92651
Correspondent Contact MARY LOU MOONEY
Regulation Number874.4780
Classification Product Code
LYA  
Date Received08/30/2013
Decision Date 01/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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