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510(k) K002765

LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE by Integra Neurosciences — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2000
Date Received
September 5, 2000
Clearance Type
Traditional
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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  • K021989 — SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (September 13, 2002)
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  • 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)

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