NeuraGen 3D Nerve Guide Matrix— 510(k) K163457
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K163457 for NeuraGen 3D Nerve Guide Matrix, Substantially Equivalent on 2017-01-06. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code JXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Planisboro, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.