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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 K063308
Device Name ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
Applicant
Carbylan Biosurgery
3181 Porter Dr.
Palo Alto,  CA  94304
Applicant Contact ROXANNE DUBOIS
Correspondent
Carbylan Biosurgery
3181 Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact ROXANNE DUBOIS
Regulation Number874.4780
Classification Product Code
LYA  
Date Received11/02/2006
Decision Date 12/04/2006
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
Predetermined Change
Control Plan Authorized		 No
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