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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 K011676
Device Name VIVAWAVE MICROWAVE SYSTEM
Original Applicant
VIVANT MEDICAL, INC.
1916-a old middlefield way
mountain view,  CA  94043
Original Contact steven kim
Regulation Number878.4400
Classification Product Code
NEY  
Subsequent Product Code
GEI  
Date Received05/30/2001
Decision Date 06/18/2002
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
Recalls CDRH Recalls
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