FDA 510(k) Application Details - K003983

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K003983
Device Name Stimulator, Nerve, Battery-Powered
Applicant STOCKERT GMBH
BOTZINGER STRABE 72
FREIBURG D-79111 DE
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Contact DOMINIKA SCHULER
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Regulation Number 868.2775

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Classification Product Code BXN
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Date Received 12/26/2000
Decision Date 06/06/2001
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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