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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K173409
Device Name Wireless Audio System
Applicant
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Applicant Contact Michael Leigh
Correspondent
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Correspondent Contact Michael Leigh
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/01/2017
Decision Date 02/16/2018
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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