FDA 510(k) Application Details - K964433

Device Classification Name Electrode, Cutaneous

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510(K) Number K964433
Device Name Electrode, Cutaneous
Applicant MEDIBOND LTD.
POB 6718
EFRAT 90435 IL
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Contact ELI M ORBACH
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 11/05/1996
Decision Date 01/27/1997
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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