FDA 510(k) Application Details - K230415

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K230415
Device Name Stimulator, Electrical, Evoked Response
Applicant Cadwell Industries, Inc.
909 North Kellogg Street
Kennewick, WA 99336 US
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Contact Jason Ford
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 02/16/2023
Decision Date 08/17/2023
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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