FDA 510(k) Application Details - K061172

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K061172
Device Name Stimulator, Nerve, Battery-Powered
Applicant PAJUNK GMBH MEDIZINTECHNOLOGIE
106 EAST 5TH AVENUE
MOUNT DORA, FL 32757 US
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Contact LYNETTE L HOWARD
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Regulation Number 868.2775

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Classification Product Code BXN
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Date Received 04/27/2006
Decision Date 10/17/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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