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FDA 510(k) Application Details - K101372
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K101372
Device Name
Probe, Radiofrequency Lesion
Applicant
BAYLIS MEDICAL CO., INC.
2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 5S4 CA
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Contact
MEGHAL KHAKHAR
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
05/17/2010
Decision Date
08/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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