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