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510(k) K020558

LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE by Integra Neurosciences — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2002
Date Received
February 20, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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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)
  • K002765 — LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTROD (November 24, 2000)

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