NEURAGEN 3D— 510(k) K130557
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K130557 for NEURAGEN 3D, Substantially Equivalent on 2014-04-24. 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
- Traditional
- Location
- Planisboro, NJ, US
Recent devices under product code JXI
view allMore clearances from Integra LifeSciences Corporation
view all- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
Data sourced from openFDA. This site is unofficial and independent of the FDA.