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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 K153686
Device Name SPIWay Endonasal Access Guide
Applicant
SPIWAY LLC
1120 CALLE CORDILLERA, #102
SAN CLEMENTE,  CA  92673
Applicant Contact EUGENE CHEN
Correspondent
SPIWAY LLC
1120 CALLE CORDILLERA, #102
SAN CLEMENTE,  CA  92673
Correspondent Contact MARY LOU MOONEY
Regulation Number874.4780
Classification Product Code
LYA  
Date Received12/23/2015
Decision Date 01/28/2016
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
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