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FDA 510(k) Application Details - K242841
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K242841
Device Name
Probe, Radiofrequency Lesion
Applicant
Abbott Medical
6901 Preston Road
Plano, TX 75024 US
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Contact
Elijah Canal
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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
09/19/2024
Decision Date
05/27/2025
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
FDA Source Information for K242841
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