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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name probe, radiofrequency lesion
510(k) Number K121773
Model NIMI7-100-10BB
Device Name NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
Original Applicant
BIOMERICS
2700 s 900 w
salt lake city,  UT  84119
Original Contact emily madsen
Regulation Number882.4725
Classification Product Code
GXI  
Date Received06/18/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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