FDA 510(k) Application Details - K983597

Device Classification Name Electrode, Needle

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510(K) Number K983597
Device Name Electrode, Needle
Applicant MEDICOTEST, INC.
1900 K STREET, N.W.
WASHINGTON, DC 20006-1108 US
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Contact EMALEE G MURPHY
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 10/13/1998
Decision Date 01/11/1999
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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