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510(k) K001096

BURR HOLE COVER, MODEL XX by Image-Guided Neurologics, Inc. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2000
Date Received
April 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

Other clearances by Image-Guided Neurologics, Inc.

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  • K040834 — NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 (June 3, 2004)
  • K033619 — NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 (March 2, 2004)
  • K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (August 21, 2003)
  • K024201 — NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 (March 12, 2003)
  • K023949 — NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES (February 25, 2003)
  • K022100 — NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1 (September 25, 2002)
  • K012719 — NAVIGUS II MR (October 22, 2001)

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