FDA 510(k) Application Details - K950314

Device Classification Name Electrode, Needle

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510(K) Number K950314
Device Name Electrode, Needle
Applicant DANTEC MEDICAL, INC.
1575 EYE STREET, N.W.
WASHINGTON, DC 20005 US
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Contact RICHARD D MANTHEI
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 01/26/1995
Decision Date 03/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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