FDA 510(k) Application Details - K222281

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K222281
Device Name Probe, Radiofrequency Lesion
Applicant Relievant Medsystems, Inc.
1230 Midas Way, Suite 200
Sunnyvale, CA 94085 US
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Contact Thomas A. Slater
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 07/29/2022
Decision Date 10/26/2022
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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