FDA 510(k) Application Details - K242841

Device Classification Name Probe, Radiofrequency Lesion

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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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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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