FDA 510(k) Application Details - K032833

Device Classification Name Electrode, Cutaneous

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510(K) Number K032833
Device Name Electrode, Cutaneous
Applicant OTTO BOCK HEALTH CARE, LP
2 CARLSON PWY. STE. 100
MINNEAPOLIS, MN 55447-4467 US
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Contact BERT HARMAN
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 09/11/2003
Decision Date 09/23/2003
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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