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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 K122217
Model CERTUS 140
Device Name CERTUS 140 2.45GHZ ABLATION SYSTEM
Applicant
NEUWAVE MEDICAL, INC
3529 anderson street
madison,  WI  53704
Contact dan kosednar
Regulation Number878.4400
Classification Product Code
NEY  
Date Received07/25/2012
Decision Date 12/19/2012
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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