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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K162623
Device Name 16ch T/R Hand Wrist Coil
Applicant
QUALITY ELECTRODYNAMICS, LLC
6655 BETA DRIVE SUITE 100
MAYFIELD VILLAGE,  OH  44143
Applicant Contact KATHLEEN ARAS
Correspondent
QUALITY ELECTRODYNAMICS, LLC
6655 BETA DRIVE SUITE 100
MAYFIELD VILLAGE,  OH  44143
Correspondent Contact KATHLEEN ARAS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/20/2016
Decision Date 12/09/2016
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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