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FDA 510(k) Application Details - K090955
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K090955
Device Name
Probe, Radiofrequency Lesion
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact
MASON W ROBBINS
Other 510(k) Applications for this Contact
Regulation Number
882.4725
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Classification Product Code
GXI
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More FDA Info for this Product Code
Date Received
04/06/2009
Decision Date
07/16/2009
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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