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FDA 510(k) Application Details - K032196
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K032196
Device Name
Probe, Radiofrequency Lesion
Applicant
NEW BUSINESS DEVELOPMENT, LLC
605 INDUSTRIAL COURT
WOODSTOCK, GA 30189 US
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Contact
TIMOTHY B LUSBY
Other 510(k) Applications for this Contact
Regulation Number
882.4725
More FDA Info for this Regulation Number
Classification Product Code
GXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2003
Decision Date
10/09/2003
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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