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FDA 510(k) Application Details - K090866
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K090866
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
NEUROMED DEVICES, INC
29461 TROON ST
LAGUNA NIGEL, CA 92677 US
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ROBERT SEIPLE
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Regulation Number
882.5890
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Classification Product Code
GZJ
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Date Received
03/31/2009
Decision Date
10/21/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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