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510(k) K042277

SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM by Integra Neurosciences, Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2004
Date Received
August 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Integra Neurosciences, Ltd.

  • K082250 — AURAGEN CORTICAL SURFACE ELECTRODES (October 10, 2008)
  • K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, (May 11, 2005)
  • 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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