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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 K092401
Device Name SINEXUS SINUS STENT GEN 2, MODEL 1999-25
Applicant
SINEXUS, INC.
1049 ELWELL CT.
PALO ALTO,  CA  94303
Applicant Contact AMY CONUEL
Correspondent
SINEXUS, INC.
1049 ELWELL CT.
PALO ALTO,  CA  94303
Correspondent Contact AMY CONUEL
Regulation Number874.4780
Classification Product Code
LYA  
Date Received08/06/2009
Decision Date 11/17/2009
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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