FDA 510(k) Application Details - K962455

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K962455
Device Name Stimulator, Electrical, Evoked Response
Applicant CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK, WA 99336 US
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Contact CARLTON M CADWELL
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 06/25/1996
Decision Date 01/13/1997
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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