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510(k) K082250

AURAGEN CORTICAL SURFACE ELECTRODES by Integra Neurosciences — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2008
Date Received
August 8, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

Other clearances by Integra Neurosciences

  • K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, (May 11, 2005)
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  • K031086 — CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 (May 14, 2003)
  • K021989 — SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (September 13, 2002)
  • K022554 — MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 23, 2002)
  • K022553 — CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MO (August 20, 2002)
  • K020558 — LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE (March 21, 2002)
  • K002765 — LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTROD (November 24, 2000)

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