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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 K071611
Device Name NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
Applicant
NEOCOIL
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 DNAIEL W LEHTONEN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/13/2007
Decision Date 06/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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