FDA 510(k) Application Details - K051635

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K051635
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM, MA 02492 US
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Contact JOEL C KENT
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 06/20/2005
Decision Date 07/15/2005
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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