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FDA 510(k) Application Details - K062616
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K062616
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
INTELSOURCE GROUP, INC.
1676 VILLAGE GREEN
SUITE A
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
GZJ
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More FDA Info for this Product Code
Date Received
09/05/2006
Decision Date
07/06/2007
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
N
Expedited Review
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