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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 K070496
Device Name ADVACOAT SINUS GEL AND STENT
Applicant
CARBYLAN BIOSURGERY
3181 PORTER DRIVE
PALO ALTO,  CA  94304
Applicant Contact ROXANNE DUBOIS
Correspondent
CARBYLAN BIOSURGERY
3181 PORTER DRIVE
PALO ALTO,  CA  94304
Correspondent Contact ROXANNE DUBOIS
Regulation Number874.4780
Classification Product Code
LYA  
Date Received02/20/2007
Decision Date 03/15/2007
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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