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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 K152933
Device Name Vesalius
Applicant
Telea Electronic Engineering Srl
Via Leonardo Da Vinci 13
Sandrigo,  IT 36066
Applicant Contact Simona Daidone
Correspondent
THEMA S.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Simona Daidone
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/05/2015
Decision Date 03/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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