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510(k) K053363

DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES by Ad-Tech Medical Instrument Corp — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2006
Date Received
December 2, 2005
Clearance Type
Abbreviated
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

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  • K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE (November 2, 1999)
  • K992194 — CORTICAL MAPPING UNIT, MODEL CMU (September 13, 1999)
  • K973454 — AD-TECH'S SPINAL ELECTRODE (June 10, 1998)
  • K964644 — AD-TECH'S DEPTH ELECTRODE (May 9, 1997)
  • K970587 — AD-TECH SUBDURAL ELECTRODE (May 9, 1997)
  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K944061 — CUEVA CRANIAL NERVE ELECTRODE (January 20, 1995)

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