COVAMAX RESORBABLE COLLAGEN MEMBRANE
FDA 510(k) clearance K103087 · decided 2011-08-26
Clearance details
- K-number
- K103087
- Device name
- COVAMAX RESORBABLE COLLAGEN MEMBRANE
- Applicant
- Biom'Up Sas
- Decision
- Substantially Equivalent
- Date received
- 2010-10-19
- Decision date
- 2011-08-26
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- NPL
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- St-Priest, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures. recall (Z-1110-2017) | Biom'up | 2017-01-27 |