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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K150313
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 Number892.2050
Classification Product Code
LLZ  
Date Received02/09/2015
Decision Date 07/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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