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510(k) K970587

AD-TECH SUBDURAL ELECTRODE by Ad-Tech Medical Instrument Corp — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
February 18, 1997
Clearance Type
Traditional
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

Other clearances by Ad-Tech Medical Instrument Corp

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  • K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRA (May 30, 2006)
  • K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTROD (May 25, 2006)
  • K041604 — MACRO-MICRO DEPTH ELECTRODE (August 16, 2004)
  • 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)
  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K944061 — CUEVA CRANIAL NERVE ELECTRODE (January 20, 1995)

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