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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 K103342
Device Name 3.0T METAFLEXCOIL
Applicant
NEOCOIL, LLC
N27 W23910A PAUL RD.
PEWAUKEE,  WI  53072
Applicant Contact BRIAN BROWN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/15/2010
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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