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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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RAINER MAAS
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Regulation Number
868.2775
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Classification Product Code
BXN
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More FDA Info for this Product Code
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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