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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 K134036
Device Name WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
Applicant
Loktal Medical Electronics Ind. Com. Ltda- Epp
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact Carrie Hetrick
Correspondent
Loktal Medical Electronics Ind. Com. Ltda- Epp
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/31/2013
Decision Date 10/08/2015
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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