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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, ablation, microwave and accessories
510(k) Number K113237
Model CERTUS 140
Device Name CERTUS 140 2.45GHZ ABLATION SYSTEM
Original Applicant
NEUWAVE MEDICAL, INC.
3529 anderson st
madison,  WI  53704
Original Contact dan kosednar
Regulation Number878.4400
Classification Product Code
NEY  
Date Received11/02/2011
Decision Date 01/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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