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FDA 510(k) Application Details - K032055
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K032055
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
MEDICAL EQUIPMENT DEVICE SPECIALISTS
9811 W. CHARLESTON #2387
LAS VEGAS, NV 89117 US
Other 510(k) Applications for this Company
Contact
C. A. TEKLINSKI
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/02/2003
Decision Date
10/03/2003
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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