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FDA 510(k) Application Details - K013210
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K013210
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
DAN MED, INC.
4 WEST DRY CREEK CIRCLE,
SUITE 260
DENVER, CO 80120 US
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Contact
THOMAS SANDGAARD
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2001
Decision Date
04/04/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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