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FDA 510(k) Application Details - K023424
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K023424
Device Name
Neurological Stereotaxic Instrument
Applicant
DENX ADVANCED DENTAL SYSTEMS
MIZPE AVIV, INDUSTRIAL PARK 13
M.P. MISGAV 20187 IL
Other 510(k) Applications for this Company
Contact
KOBY BEN-BARAK
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2002
Decision Date
05/09/2003
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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