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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 K093693
Device Name NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
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  
Date Received11/30/2009
Decision Date 01/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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