ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200— 510(k) K063308

Substantially Equivalent

Carbylan Biosurgery

FDA 510(k) clearance K063308 for ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200, Substantially Equivalent on 2006-12-04. Applicant: Carbylan Biosurgery. Device class: 1.

Clearance details

Applicant
Carbylan Biosurgery
Product code
Code LYA
Device class
Class 1
Regulation
21 CFR 874.4780
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palo Alto, CA, US
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