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510(k) K073532

DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES by Technomed Europe — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2008
Date Received
December 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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

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