FDA 510(k) Application Details - K052313

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K052313
Device Name Stimulator, Nerve, Battery-Powered
Applicant STOCKERT GMBH
BOETZINGER STRASSE 72
FREIBURG, B-W 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 08/25/2005
Decision Date 11/17/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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