BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
FDA 510(k) clearance K992216 · decided 1999-07-26
Clearance details
- K-number
- K992216
- Device name
- BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-01
- Decision date
- 1999-07-26
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BioMend Extend" Absorbable Collagen Membrane BioMend Extend" Absorbable Collagen Membrane recall (Z-1299-2013) | Integra LifeSciences Corporation | 2013-05-10 |