FDA 510(k) Application Details - K111717

Device Classification Name Media, Electroconductive

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510(K) Number K111717
Device Name Media, Electroconductive
Applicant ELECTRO-CAP INTL., INC.
1011 WEST LEXINGTON RD.
EATON, OH 45320 US
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Contact AMY B SWALLOWS
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Regulation Number 882.1275

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Classification Product Code GYB
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Date Received 06/20/2011
Decision Date 01/05/2012
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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