FDA 510(k) Application Details - K981015

Device Classification Name Electrode, Depth

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510(K) Number K981015
Device Name Electrode, Depth
Applicant PREFERRED INSTRUMENTS
5202 WASHINGTON ST.
DOWNERS GROVE, IL 60515 US
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Contact CHARLES W SCOUTEN, PH.D.
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Regulation Number 882.1330

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Classification Product Code GZL
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Date Received 03/18/1998
Decision Date 06/16/1998
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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