BIOROOT RCS— 510(k) K130601
Substantially EquivalentNovocol, Inc.
FDA 510(k) clearance K130601 for BIOROOT RCS, Substantially Equivalent on 2013-10-17. Applicant: Novocol, Inc.. Device class: 2.
Clearance details
- Applicant
- Novocol, Inc.
- Product code
- Code KIF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3820
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Louisville, CO, US
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