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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 K082373
Device Name NORAS MR-BI320-PA 3T
Applicant
Noras Mri Products GmbH
Leibnitzstrasse 4
Hoechberg,  DE 97204
Applicant Contact PATRICIA KRAPF
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/18/2008
Decision Date 08/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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