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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K113500
FOIA Releasable 510(k) K113500
Device Name CANADY VIEIRA HYBRID PLASMA SCALPEL
Applicant
US MEDICAL INNOVATIONS LLC
2940 winter lake road
lakeland,  FL  33803
Applicant Contact jerome canady
Correspondent
TUV SUD AMERICA INC.
1775 old highway 8 nw
new brighton,  MN  55112 -1891
Correspondent Contact norbert stuiber
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/25/2011
Decision Date 12/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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