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FDA 510(k) Application Details - K090608
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K090608
Device Name
Probe, Radiofrequency Lesion
Applicant
MINTA MEDICAL LIMITED
CADDICK ROAD
KNOWSLEY MERSEYSIDE L34 9HP GB
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Contact
ANDREW EDWARDS
Other 510(k) Applications for this Contact
Regulation Number
882.4725
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Classification Product Code
GXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/06/2009
Decision Date
06/14/2010
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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