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FDA 510(k) Application Details - K002389
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K002389
Device Name
Probe, Radiofrequency Lesion
Applicant
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 5
MISSISSAUGA L4W-4T7 CA
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Contact
KRIS SHAH
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
08/04/2000
Decision Date
10/23/2000
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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