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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 K133506
Device Name NORAS OR HEAD HOLDER FLEXIBILITY
Applicant
Noras Mri Products GmbH
Leibnitzstrasse 4
Hoechberg,  DE 97204
Applicant Contact ZAHED SEDIGHIANI
Correspondent
Noras Mri Products GmbH
Leibnitzstrasse 4
Hoechberg,  DE 97204
Correspondent Contact ZAHED SEDIGHIANI
Regulation Number892.1000
Classification Product Code
MOS  
Subsequent Product Code
HBL  
Date Received11/14/2013
Decision Date 08/06/2014
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
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