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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 K150364
Device Name ERBE ESU Model VIO dV with Accessories
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Applicant Contact Axel Retzlaff
Correspondent
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Correspondent Contact Axel Retzlaff
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/12/2015
Decision Date 05/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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