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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 K152703
Device Name PlasmaBlade TnA Tonsil and Adenoid Dissection Device
Applicant
Medtronic Advanced Energy
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact LYDIA SAKAKEENY
Correspondent
Medtronic Advanced Energy
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact LYDIA SAKAKEENY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/21/2015
Decision Date 07/08/2016
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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