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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 K141832
Device Name 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
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
MOS  
Date Received07/07/2014
Decision Date 07/31/2014
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
Recalls CDRH Recalls
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