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510(k) K063729

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 by Technomed Europe — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2007
Date Received
December 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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  • K042375 — SMK, CX, CXE, RCN (October 26, 2004)

Other clearances for product code GXZ

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  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)