FDA 510(k) Application Details - K992598

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K992598
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712 US
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Contact REBECCA A RIVAS
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 08/03/1999
Decision Date 08/30/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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