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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
Device Name CANADY VIEIRA HYBRID PLASMA SCALPEL
Original Applicant
US MEDICAL INNOVATIONS LLC
2940 winter lake road
lakeland,  FL  33803
Original Contact jerome canady
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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