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FDA 510(k) Application Details - K023435
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K023435
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
MEDICAL EQUIPMENT DEVICE SPECIALISTS
32158 CAMINO CAPISTRANO
SUITE A-416
SAN JUAN CAPISTRANO, CA 92675 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
10/15/2002
Decision Date
01/13/2003
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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