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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 K132974
Device Name AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
Applicant
Medtronic Advanced Energy, LLC
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact GABRIELA ANCHONDO
Correspondent
Medtronic Advanced Energy, LLC
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact GABRIELA ANCHONDO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/2013
Decision Date 12/03/2013
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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