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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 K122762
Model ACCU2I PART NO.'S 900-600,900-601,900-602
Device Name ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
Original Applicant
MICROSULIS MEDICAL LIMITED
unit 1 and 2 falson court
parklands business park
denmead,  UK po7 7xp
Original Contact stuart mcintyre
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/10/2012
Decision Date 11/30/2012
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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