FDA 510(k) Application Details - K091155

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K091155
Device Name Stimulator, Nerve, Battery-Powered
Applicant NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM, MA 02451 US
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Contact RAINER MAAS
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Regulation Number 868.2775

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Classification Product Code BXN
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Date Received 04/21/2009
Decision Date 09/03/2009
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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