FDA 510(k) Application Details - K073532

Device Classification Name Electrode, Cutaneous

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510(K) Number K073532
Device Name Electrode, Cutaneous
Applicant TECHNOMED EUROPE
AMERIKALAAN 71
MAASTRICHT AIRPORT 6199 AE NL
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Contact MAURICE ROOST
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 12/17/2007
Decision Date 05/01/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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