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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K163118
Device Name FLEX Microwave Ablation System and Accessories
Applicant
Neuwave Medical, Inc.
3529 Anderson St.
Madision,  WI  53704
Applicant Contact DAN KOSEDNAR
Correspondent
Neuwave Medical, Inc.
3529 Anderson St.
Madision,  WI  53704
Correspondent Contact DAN KOSEDNAR
Regulation Number878.4400
Classification Product Code
NEY  
Date Received11/08/2016
Decision Date 03/09/2017
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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