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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K161285
Device Name Ablation Confirmation
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 Number892.1750
Classification Product Code
JAK  
Date Received05/09/2016
Decision Date 06/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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