FDA 510(k) Application Details - K062478

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K062478
Device Name Stimulator, Nerve, Battery-Powered
Applicant MEDTRONIC A/S
16-18 TONSBAKKEN
SKOVLUNDE DK-2740 DK
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Contact ANN-CHRISTINE PROVOOST
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Regulation Number 868.2775

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Classification Product Code BXN
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Date Received 08/24/2006
Decision Date 02/08/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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