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FDA 510(k) Application Details - K103103
Device Classification Name
Electrode, Needle
More FDA Info for this Device
510(K) Number
K103103
Device Name
Electrode, Needle
Applicant
PERSYST DEVELOPMENT CORP.
3177 CLEARWATER DRIVE
PRESCOTT, AZ 86305 US
Other 510(k) Applications for this Company
Contact
SCOTT B WILSON
Other 510(k) Applications for this Contact
Regulation Number
882.1350
More FDA Info for this Regulation Number
Classification Product Code
GXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2010
Decision Date
12/08/2011
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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